Registration Certificates issued for the Medical Devices along with their manufacturing sites and Indian Authorized
Agents from Jan. 2012 to Dec 2012
S.
No.
Name of Indian Agent
Name of Manufacturer
Name of the Device
File No.
R. C. No.
Date of
Issue
1.
M/s. Spinemed System
Private Limited, 501, 5th
Floor, 90 Mansarovar
Building, Nehru Place,
New Delhi-110019
M/s. Extermity Medical
LLC, 300 Interpace
Parkway, Suite 410,
Parsippany New Jersy07054, USA
31-803 (A)-MD/2010-DC
MD-803 (A)
3-01-2012
2.
M/s. BL Lifesciences
Private Limited, A-245,
Okhla Industrial Area,
Phase-I, New Delhi110020
M/s. Rontis AG,
Bahnhofstrasse 7, CH6301 Zug, Switzerland
31-981-MD/2011-DC
MD-981
3-01-2012
15-12-2014
3.
M/s. Terumo Corporation
Chennai Branch,
Alexander Square, 4th
Floor, 34 & 35, Sardar
Patel Road, Guindy,
Chennai-600032
M/s. DePuy Medical
private Limited, 64-66
Senapati Bapat Marg,
Mahim, Mumbai-400016
M/s. Vascytek Limited, a
Terumo Co, Newmains
Avenue, Inchinnan,
Renfrewshire, PA49RR,
Scotland
Extermity Medical Orthopedic
Implants, Non sterile, Titanium
Alloy (consisting of Screws
(CompressX Implants, TarsX
Implants, HalluX Implants IO Fix
Implants and XMCP Implants)
Drugs Eluting Stent Systems
Coronary Stent Systems
PTCA Balloons
Coronary GuideWire
PTA Balloon Catheter
Pheripheral Stent System
Anaconda Stent Graft System
Validity of
the
Registratio
n
Certificate
15-12-2014
31-880-MD/2010-DC (End
01)
MD-880
3-01-2012
14-06-2014
Sigma High Performance (HP)
Partial Knee System
31-128-MD/2006-DC (ReReg. 2009) End 01
MD-128
4-01-2012
14-04-2013
Durolane (Hyaluronic Acid,
31-1012-MD/2011-DC
MD-1012
4-01-2012
15-12-2014
4.
5.
M/s. Smith & Nephew
M/s. DePuy Orthopaedics
Inc, PO Box 988, 700
Orthopaedics Drive
Warsaw, Indiana 465810988, USA having factory
premises at M/s. DePuy
Orthopedics Inc, 325
Paramount Drive,
Raynham, MA 02767,
USA
M/s. Smith & Nephew Inc,
1
6.
7.
8.
9.
10.
Healthcare Private
Limited, Logistic Sherbos
Agencies, Minakshi
Industrial Estate, Gala-7,
Building-1, Naikpada, WE
Highway, Vasai (E),
Maharashtra-410208
M/s. Osstem Implant India
Private Limited, 418, A
Wing, Sagartech Plaza,
Sakinaka, Andheri Kurla
Road, Andheri (E),
Mumbai-400072
M/s. Bausch & Lomb
Eyecare India Private
Limited, Rajendra
Bhawan, 210, Deen dayal
Upadhyay Marg, New
Delhi-110002
M/s. Cosmos Enterprises,
S-5, Sadhana Building,
Asani Housing Complex,
kandivalil (W), Mumbai400067
M/s. Teleflex Medical
private Limited, Old No. 10
No. 19, 1st Floor, & Ground
Floor, Harrington Road,
Chetpett, Chennai-600031
M/s. Atrium Medical India
1450 E Brooks Road,
Memphis, Tennesse
38116, USA having
manufacturing premises
at M/s. Q-Med AB,
Seminariegatan 21, SE752 28, Uppsala, Sweden
M/s. Osstem Implant Co.
Limited, Manufacturing
Division, #507-8, Geoje3kong, Yeonje-gu, Busan
611-804, Korea
Stabilized Single Injection)
20mg/ml)
Dental Implant Fixture
Dental Implant System
Prosthetics
31-965-MD/2011-DC
MD-965
4-01-2012
15-12-2014
M/s. Bausch & Lomb
Incorporated, 1400 North,
Goodman Street,
Rochester, NY 14609,
USA having factory
premises at M/s. Bausch
& Lomb Incorporated, 21
Park Place Blvd, North,
Clearwater Florida,
33759, USA
M/s. Natec Medical
Limited, Maeva Building
Ebene Center Business
Park, Reduit Mauritius
enVista HydroStable Acrylic AO
Lens
31-11-MD/2006-DC (ReReg. 2009) End 02
MD-11
5-01-2012
31-10-2012
Tamarin Blue PTCA Catheters
31-919-MD/2011-DC
MD-919
5-01-2012
15-12-2014
M/s. Arrow International
icn, 2400 Bernville Road,
Reading Pensylvania
19605 USA having
factory premises at M/s.
Arrow International CR,
a.s. Jamska 2359/47,
Zdar nad sazanou 59101
Czech Republic
M/s. Atrium Medical
Epidural Catheters
Thermodilution Balloon
Catheters
Central Venous Catheters
Acute Hemodialysis Catheters
31-882-MD/2011-DC
MD-882
10-01-2012
31-12-2014
Family of C-Qur Mesh
31-524-MD/2008-DC (re-
MD-524
10-01-2012
30-11-2014
2
11.
12.
13.
14.
Private Limited, Old No.
54, New No. 11, NRD
Tower, 3rd Floor, First
Avenue, Jawaharlal Nehru
Road, Ashok Nagar,
Chennai-83
M/s. 3M India Limited,
Survey No. 48/3, K.Nop.
927/912, 897
Hongasandra Village, 7th
Mile Hosur Road,
Bangalore-560068
M/s. B. Braun Medical
India Private Limited, 5th
Floor, East Quadrant The
IL & FS Financial Centre,
Bandra Kurla Complex,
Bandra (E), Mumbai400051
M/s. Apothecaries Private
Limited, 579, devil East of
Sainik Farms, New Delhi110062
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building No. 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri (E),
Mumbai-400093
Corporation, 5,
Wentworth Drive Hudson,
New Hampshire 03051,
USA
reg. 2011) End 01
M/s. 3M Health Care, St.
Paul Minnesota 551441000, USA having factory
premises at M/s. 3M
Healthcare, 3M
Brookings, 601, 22nd Ave.
South Brookings, South
Dakota 57006, USA
M/s. B. Braun Melsungen
AG, Germany having
factory premises at M/s.
B. Braun Medical KFT
Deli-Kulhar UT 2-4 3200
Gyongyos Hungary
3M Tegaderm Diamond Film
Diamond Pattern Film Dressings
31-874-MD/2010-DC (End
03)
MD-874
10-01-2012
15-11-2014
IV Administration Set-Intrafix
6-4/FF-432/10/2007-DC
(Re-Reg. 2009) End 01)
(MD)
FF-432
10-01-2012
31-07-2013
M/s. Hoya Corporation, 27-5 Naka Ochiai,
Shinjuku-Ku, Tokyo 1618525 Japan, Having
factory premises at M/s.
Hoya medical Singapore
Pte Limited, 455A Jalan
Ahmed Ibrahim 639939
Singapore
M/s. Medtronic Inc, 710,
Medtronic Park Way, NE
Minneapolis MN-55432,
USA having factory
premise s at M/s.
Medtronic Ireland
Parkmore Business Park
West Galway, Ireland
Hoya-PS AF-1 (UV) Intraocular
Lens PC-60R
31-701-MD/2009-DC (End
02)
MD-701
10-01-2012
30-11-2012
C315 Delivery Catheter
31-64-MD/2006-DC (ReReg. 2009) End 03
MD-64
10-01-2012
31-07-2012
3
15.
M/s. St. Jude Medical
India Private Limited, Plot
No. 18 & 19 Laxminagar,
behind TB Hospital,
Hyderabad-500038
M/s. St. Jude Medical
Puerto Rico LLC, Lot 20B, St. Cagaus Puerto
Rico 00725
St. Jude Medical Mechanical
Heart Valve SJM Master Series
(Rotatable)-Aortic + 9
31-28-MD/2006-DC (ReReg. 2_
MD-28
23-01-2012
30-06-2015
16.
M/s. Apothecaries Private
Limited, 579, devil East of
Sainik Farms, New Delhi110062
Hoya iSert 251
31-701-MD/2009-DC (End
03)
MD-701
24-01-2012
30-11-2012
17.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
District-Thane, Bhiwandi
Empira Rx PTCA Dilation
catheter
Empira NC Rx PTCA Dilation
Catheter
31-991-MD/2011-DC
MD-991
24-01-2012
14-01-2015
18.
M/s. Becton Dickinson
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Medhavaram,
Chennai-51
BD Eclipse Needle with
smartSlip Technology
31-868-MD/2010-DC
MD-868
24-01-2012
31-12-2014
19.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
M/s. Hoya Corporation, 27-5 Naka Ochiai,
Shinjuku-Ku, Tokyo 1618525 Japan, Having
factory premises at M/s.
Hoya medical Singapore
Pte Limited, 455A Jalan
Ahmed Ibrahim 639939
Singapore
M/s Creganna-Tactx
Medical Inc, 1353 Dell
Avenue, Campbell, CA
95008, USA having
factory premises at M/s.
Creganna Tactx Medical
Pte Limited, 29
Woodlands Industrial
Park E1, #04-13/14,
Northtech Lobby 3
Singapore-757716
M/s. Becton Dickinson &
Co., 1 Becton Drive,
Franklin Lakes NJ 07417,
USA having factory
premises at M/s. Becton
Dickinson SA Ctra
Mequinenza, s/n 22520
Fraga (Huesca) Espana,
Spain
M/s. Boston Scientific
Corporation, Boston
Scientific Place, Natick,
Promus Element Plus
Everolimus-Eluting Coronary
Stent System
31-41A-MD/2006-DC (Rereg. 2009) End 05
MD-41A
24-01-2012
31-03-2013
4
Plame Marg, Munirka,
New Delhi-110067
20.
21.
M/s. Advanced Life
Science Private Limited,
D-22 Okhla Industrial
Area, pHase-I, New Delhi110020
M/s. Apothecaries Private
Limited, 579, devil East of
Sainik Farms, New Delhi110062
22.
M/s. Polu Medicure
Limited, Plot No. 104-105,
Sector-59, HSIDC
Industrial Area,
Ballabgarh, Faridabad-
23.
M/s. Manju Enterprises
Private Limited, 28, 1st
Floor, Jia Sarai, New
Delhi-110016
M/s. Zimmer India Private
Limited, Plot No. B & B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
M/s. Biomet Orthopaedics
India Private Limited,
24.
25.
Massachusetts 017601537, USA having factory
premises at M/s. Boston
Scientific Ireland Limited,
Ballybrit Business Park,
Galway, Ireland
M/s. Z-Medica
Corporation, 4 Fairfield
Boulevard, Walingford,
Connecticut 06492, USA
QuickClot eX Kaolin based
Family of Products
QuickClot Interventional
Hemostatic Bandages
31-930-MD/2011-DC
MD-930
24-01-2012
14-01-2015
M/s. Hoya Corporation, 27-5 Naka Ochiai,
Shinjuku-Ku, Tokyo 1618525 Japan, Having
factory premises at M/s.
Hoya medical Singapore
Pte Limited, 455A Jalan
Ahmed Ibrahim 639939
Singapore
M/s. Abu Dhabi Medical
Devices Co. LLC
“Medeco” Plot No. M-43,
Block No. 124, Mussafah
Industrial Area, P.O. Box
30485, Abu Dhabi UAE
M/s. Iberhospitex SA
Avda de Catalunya 4
08185 Llica de Vall
(Barcelona) Espana
M/s. Aap Biomaterials
GmbH, Lagerstrasse, 1115, D-64807 Dieburg,
Germany
Hoya-PS AF-1 (UY) Intraocular
Lens PY-60R
31-701-MD/2009-DC (End
01)
MD-701
24-01-2012
30-11-2012
Auto Disable Syringes
31-371-MD/2007-DC (Rereg. 2011)
MD-371
24-01-2012
31-12-2014
Hunter Thrombus Extractor
Catheter
31-12A-MD/2006-DC (Rereg. 2009) End 01
MD-12A
24-01-2012
30-06-2012
Hi-Fatigue Bone Cement
Hi-Fatigue G Bone Cement
31-960-MD/2011-DC
MD-960
30-01-2012
31-12-2014
M/s. Biomet Microfixation
1520 Tradeport Drive,
Total Temporomandibular Joint
(TMJ) System
31-910-MD/2011-DC
MD-910
30-01-2012
14-01-2015
5
2301, Shanti Estate,
Ghansham Estate,
National Highway No. 8,
Aslali, Tal: Daskroi
Jacksonville, FL 32218,
USA
26.
M/s. Romsons Medicons,
E-20, Foundry Nagar,
Agra-282006
27.
M/s. Lifetech India Inc, Old
No. 14A, New No. 4,
Jagadambiga Street,
Thiruvalleswar Nagar,
Anna Nagar (W), Chennai600040
M/s. Teleflex Medical Pvt.
Ltd., Old No: 10, No: 19,
Ist Floor and Ground
Floor, Harrington Road,
Chetpet, Chennai-600 031
M/s. WRP Asia Pacific
SDN BHD, 1 Jalan 3,
Kawasan Perusahaan,
Bandar Baru Salak Tinggi
43900 Sepang Selangor
Darul Ehsan, Malaysia
M/s. Sumi Zaklad
Tworzyw Sztucznych K.
Rek A. Krzanowski
Spolka Jawna ul.
Drobiarska 35 05-070
Sulejowek, Poland
M/s. Teleflex Medical,
IDA Business and
Technology Park,
Athlo;ne, Ireland having
factory premises at M/s.
Arrow International
C.R.A.S. Jamska
2359/47, Zdar Nad
Sazavou, Czech Republic
591 01
M/s Cappella Medical
Device Limited, having
factory premises at Unit
3, Ballybrit Business
Park, Ballybrit, Galwaly,
Ireland
M/s Starway Medical
Technology Inc., having
factory premises at Suite
1007, Huijingge, No.2
Chang Wa Haidian
28.
29.
M/s Optimus Pharma
Consulting, # 1319, First
Floor 24th A Main, 9th
Block Jayanagar,
Bangalaore-560069
30.
M/s Globe Bio-Medicals,
Room /2, Juhu Apartment,
Near SNDT Collage, Juhu,
Mumbai-400 049.
Pectus Support Bar System
LactoSorb System
Craniomaxillofacial Fixation
(CMF) System
HTR-PMI Implants
Foley Balloon Catheters (Non
Sterile
Foley Balloon Catheter (Sterile)
31-496-MD/2008-DC (ReReg. 2011)
MD-496
3-02-2012
31-12-2014
Tracheal Tubes
31-918-MD/2011-DC
MD-918
13-02-2012
14-01-2015
Ureter Catheter
Ureter Stent
Percutaneous Nephrostromy
Catheter
31-932-MD/2011-DC
MD-932
29-02-2012
15-02-2015
Side Guard Cornoray Side
Branch Stent And Delivery
System (Product Codes:
SG0230002, SG0233502,
SG0238002, SG0233513,
SG0238013)
Cardi-O-Fix ASD OCCLUDER
SYSTEM, Cardio-O-Fix PDA
OCCLUDER SYSTEM, Cardi-OFix VSD OCCLUDER SYSTEM
31-1011-MD/2011-DC
MD-1011
29-02-2012
15-02-2015
31-4530MD/2008-DC (Rereg 2011)
MD-453
29-02-2012
15-02-2012
6
31.
M/s Zimmer India Private
Limited, Plot No B &B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
32.
M/s Covidien Health care
India Pvt. Ltd., “Doshi
Towers”, 6th Floor, # 156,
Poonamallee High Road,
Kilpauk, Chennai-600 010
33.
M/s. Amardeep Enterprise,
No. 5-6, 3rd Floor, Nr.
Income tax Building,
Ashram Road,
Ahmedabad, Pin: 380009
34.
M/s Hanstronics Medical
Equipment Pvt. Ltd., 2001,
Outram Line, Kingsway
Camp, Delhi-110009
35.
M/s Myovatec Surgical
Beijing, 100089, China
M/s. Zimmer GmbH
having factory premises
at Sulzer Allee 8, CH8404 Winterthur,
Switzerland
M/s Kendall-Gammatron
Co. Ltd., having factory
premises at 117 Moo 2,
Petchkasem Road,
Sampran, Nakron athom
73110, Thilland
M/s. Hydrofera LLC.,
having factory premises
at 332 Main Street,
Willimantic, Connecticut,
06226 USA.
M/s Allergan, Marlow
1.Allergretto Knee Replacement
Products
2. Total Hip Replacement
Products
3. Facture Care Products
4. Spinal Orthoapedic Implant:
Dynesys
5. Revitan Hip Stem
6. Zimmer MMCtm Cup
7. Trofix Trochanteric Fixation
Planting System
8. Metasul Taper Liner
9. Biolox Delta Taper Liner
10. Ceramic Femoral Head
11. Metal (CoCr) Femoral Head
12. Metasul Head
13. NCB® Polyaxial Locking
Plate System
31-171-MD/2006-DC (Rereg 02)
MD-171
29-02-2012
15-02-2015
Tracheal Tube Cuffed &
Uncuffed
31-748-MD/2009-DC (Rereg-200)
MD-748
29-02-2012
15-02-2012
1. 4CIS Spinal Cage
System [4COS Fusion
Cage System] [Non
Sterile]
2. 4CIS Trauma System
[Non Sterile]
Hydrofera Blue Bacteriostatic
Wound Dressings
31-383 MD/2007-DC (Rereg 2011) (End 01)
MD-383
29-02-2012
31-01-2014
31-970-MD/2011-DC
MD-970
29-02-2012
15-02-2015
31-9340MD/2011-DC
MD-934
29-02-2012
15-02-2015
1. Breast Implants
7
Systems Pvt. Ltd., TA/171/I, Tughlakabad
Extension, New Delhi110019
International Parkway
Marlow Bucks, SL7 1YL
GBR having a factory
premises at M/s Allergan,
Global Park Free Zone La
Aurora de Heredia 900
Parkway Costa Rica
M/s. Arthesys, 20 rue
Traversiere 92230
Gennevilliers, France
36.
M/s. Sahajanand Medical
Technologies Private
Limited, Sahajanand
House, Parsi Street,
Saiyedpura, Surat-395003
37.
M/s. Becton Dickinson
India Private Limited, No.
34, Assisi Nagar, West
Thottam, Modhavaram,
Chennai-51
M/s. Becton Dickinson
Medical (Singapore) Pte
Limited, 30, Tuas Avenue
2, Singapore 639461
38.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Palme Marg, Munirka,
New Delhi-110067
39.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Palme Marg, Munirka,
New Delhi-110067
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537 having
factory premises at M/s.
Boston Scientific
Corporation, 5905 Nathan
Lane, Plymouth, MN55442,
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537, USA
having factory premises
at M/s. Phillips Medical,
428 Technology Drive
East, menomonie WI
2. Tissue Exanders
Cygnus II Co-Cr Coronary Stent
System (Non Sterile)
Pegase Aspiration Catheter
(Sterile and Non Sterile)
LYNX PTA Catheter (Sterile and
Non-Sterile)
Disposable Hypodermic Needles
Disposable Hypodermic
Syringes
Disposable Hypodermic
Syringes with Needles
BD Insyte Intravenous Catheters
BD Vacutainer Flashback
Needle
Epic Self Expanding Nitinol
Vascular Stent With Delivery
System
31-274-MD/2007-DC (ReReg. 2010) End 01
MD-274
01-03-2012
14-09-2013
31-1032-MD/2011-DC
(Re-Reg. 2011)
MD-1032
01-03-2012
12-03-2015
31-164-MD/2006-DC (ReReg. 2009) End 01
MD-164
01-03-2012
14-06-2013
Expect Endoscopic Ultrasound
Aspiration Needle
31-967-MD/2011-DC
MD-967
01-03-2012
15-02-2015
8
54571, USA
40.
M/s. Med-EL India Private
Limited, 505, 5th Floor,
Pragati House, 47-48,
Nehru Place, New Delhi110019
41.
M/s. Mn Solutions, #26 &
27, 2nd Floor, WZ 26
Nangli Jalib, B-1, Janak
Puri, New Delhi-=110058
42.
M/s. Medicon Surgical
Technologies Private
Limited, 203, Damji-Shamji
Industrial Complex, 9 LBS
Marg, Kurla (W), Mumbai400070
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-0188
(Part), Chaminda Comp,
Kashelil Village, DisttThane Bhiwandi-421301
43.
44.
M/s. Sahajanand Medical
Technologies Private
Limited, Sahajanand
House, Parsi Street,
Saiyedpura, Surat-395003
45.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai-
M/s. MED-EL
Elekromedizinische
Gerate GmbH, Worldwide
Headquarters,
Furstenweg, 77a,
Innsbruck A-6020, Austria
M/s. Wright medical
Technology Inc, 5677,
Airline Road, Arlington,
TN 38002, USA
M/s. Medicon eG,
Gansacker 15, 78532
Tuttlingen, Germany
M/s. Medtronic Inc, 710
Medtronic Parkway
Minneapolis, MN-55432
having factory premises
at M/s. Medtronic Inc,
8200 Coral Sea Street
NE Mounds View,
Minnesota 55112
M/s. Arthesys, 20 rue
Traversiere 92230
Gennevilliers, France
M/s. ev3 Inc, 4600
Nathan Lane North,
Plymouth MN-55442,
USA
C 40+ Cochlear Implant System
Pulsar CI100 Cochlear Implant
System
SonataTI100 Cochlear Implant
System
31-572-MD/2008-DC (ReReg. 2011)
MD-572
01-03-2012
15-02-2015
Orthopaedic Implants
Advance Total Knee System
Total Hip System
ALLOMATRIX (Bone Void Filler)
MIIG (Bone Void Filler)
Implant Art Osteosynthesis
Distraction Devices
31-1072-MD/2012-DC
MD-1072
01-03-2012
15-02-2015
31-883-MD/2010-DC
MD-883
01-03-2012
15-02-2015
Attain Select Guide Catheter
Set, Left Heart Delivery Model
Attain Venogram Balloon
Catheter
3-966-MD/2011-DC
MD-966
01-03-2012
15-02-2015
CYGNUS II Co-Cr Coronary
Stent System (Non Sterile)
PEGASE Aspiration Catheter
(Sterile and Non Sterile)
LYNX PTA Catheter (Sterile and
Non-Sterile)
PowerCross 0.018 OTW PTA
Dilatation catheter
31-274-MD/2007-DC (ReReg. 2010) End 01
MD-274
01-03-2012
14-09-2013
31-51-MD/2006-DC (Rereg. 2011) End 01
MD-51
01-03-2012
31-03-2014
9
46.
47.
48.
600010
M/s. St. Jude Medical
India Private Limited, D.
No. 8-3-168/B/1/18 & 19,
Laxmi Nagar Mch., CircleV, Hyderabad
M/s. Friends
Consolidations Limited, D.
No. 8-2-293/82/A/281-O,
Road No. 10B, Gayathri
Hills, Jubilee Hills, MCH
Circle-5, Mandal,
Hyderabad
M/s. 3M India Limited, No.
60/16, Hosur Road,
Electronic City, Bangalore560100
49.
M/s. 3M India Limited, No.
60/16, Hosur Road,
Electronic City, Bangalore560100
50.
M/s. Zimmer India Private
Limited, Plot No. B & B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
M/s. St. Jude Medical,
177 East County Road B,
St. Paul, MN 55117, USA
having factory premises
at M/s. St. Jude Medical
Costa Rica Ltda, Edifico #
44, Calle 0, Ave 2, Zona
Franca Coyol, EI Coyol,
Alajuela, Costa Rica
M/s. Livedo Corporation,
45-2 handa-otsu,
Kanada-cho, Shikoku
chuo-shi, Ehime-ken 7990122, Japan
Epic Valve Mitral
Epic Supra Valve Aortic
Epic Valve Aortic
Trifecta Valve Aortic
31-993-MD/2011-DC
MD-993
06-03-2012
15-12-2014
Haemostatic Pad A/T
31-938-MD/2011-DC
MD-938
14-03-2012
15-02-2015
M/s. 3M Health Care, 3M
Centre, Bldg 275-5W-06,
St. Paul Minnesota,
55144-1000, USA having
factory premises at M/s.
3M Healthcare, 3M
Hutchinson 905 Adams
St. SE, Hutchinsin,
Minnesota 55350, USA
M/s. 3M ESPE Dental
Products, St. Paul,
Minnesota 55144-1000,
USA having factory
premises at M/s. 3M
ESPE Dental Products,
21211 McGaw Avenue,
Irvine, CA 92614, USA
M/s. Zimmer Inc, 1800
West Center Street,
Warsaw IN, 46580, USA
3M Nexcare Comfort bandages
3M Nexcare Waterproof
Bandages
3M Nexcare Tattoo Waterproof
Bandages
31-961-MD/2011-DC
MD-961
14-03-2012
15-02-2015
SENDAX MDI
31-873-MD/2010-DC
MD-873
14-03-2012
15-02-2015
Total Knee Replacement
Products + 12
31-170-MD/2006-DC (Rereg. 02)
MD-170
14-03-2012
31-07-2015
10
51.
Vihar-Phase-V, Gurgaon122016
M/s. Clairvoyance
Consulting, Flat No. 801,
8th Floor, Indra Prakash
Building, 21 Barakhamba
Road, New Delhi-110001
52.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
53.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-188
(Part), Chamunda Comp.
Kasheli Village, DistThane, Bhiwanid-421301
54.
M/s. Faith Biotech Private
Limited, E 107, Lajpat
Nagar-1, New Delhi0110024
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
55.
M/s. Molnlycke
Healthcare AB, Box
13080, SE-402 52
Goteborg, Sweden
having factory premise s
at M/s. Molnlycke
Healthcare Oy. P.O. Box
76, FI-50101 Mikkeli,
Finland
M/s. Covidien IIc, 15
Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s. Covidien
60 Middletown Avenue,
North Haven, CT 06473
USA
M/s. Medtronic Inc, 710
Medtronic Parkway N.E.
Minneapolis MN 55432,
USA having factory
premises at M/s.
Medtronic Heart Valves
Division, 1851 East
Deere Avenue Santa
Ana, CA 92705, USA
M/s. Micro Vention Inc,
1311 Valenvia Avenue,
Tustin, California, USA
92780
M/s. Boston Scientific
Corporation, Boston
Scientific Place, Natick,
MA 01760-1537, USA
having factory premises
Mepilex/Mepilex Heel
Mepilex Border/Mepilex Border
Sacrum
Mepitel
Mepilex Ag/ Mepilex Heel Ag
Mepiform
Mepore Film & Pad
Mepore
31-1002-MD/2011-DC
MD-1002
14-03-2012
15-02-2015
Bralon Nylon Single Stitch
Reload
Sofsilk Silk Single Stitch Reload
Surgidac Polyester Single Stitch
Reload
Surgitie Autosuture Ligating
Loop
31-949-MD/2011-DC (End
02)
MD-949
14-03-2012
14-04-2014
Hancock II Bioprosthesis
Mosaic CINCH Porcine
Bioprosthesis
Contegra Pulmonary Valved
ConduitFreestyle Aortic Root
Bioprosthesis
Duran AnCore Ring with Chordal
Guide
Profile 3D Annuloplasty Ring
Headway 17 Microcathetres
Chaperon Guiding Catheter
System
31-66-MD/2006-DC (ReReg. 02)
MD-66
14-03-2012
31-07-2015
31-804 (A)-MD/2010-DC
(End 01)
MD-804 (A)
14-03-2012
14-03-2014
Omega Monorail PtCr Coronary
Stent System
31-41A-MD/2006-DC (End
03)
MD-41A
14-03-2012
31-03-2013
11
56.
M/s. Hindustan Latex
Limited, Peroorkada Plant,
Thiruvananthapuram695005
57.
M/s. Fresenius Kabi India
Private Limited, A-3, MIDC
2nd Floor, Near
Conforance Room,
Ranjangaon Ganpati Tal.
Shirur, (Pune-Zone 1)412220
M/s. R A Market Analytics
Private Limited, B-IX, 866,
Friends Colony,
Yamunanagar-135001,
Haryana
58.
59.
60.
M/s. Zimmer India Private
Limited, Plot No. B & B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar-Phase-V, Gurgaon122016
M/s. Zimmer India Private
Limited, Plot No. B & B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar-Phase-V, Gurgaon122016
at M/s. Boston Scientific
Ireland Limited, ballybrit
Business Park, Galway,
Ireland
M/s. Pleasure Latex
Products Sdn Bhd, Lot
5322 15th Miles, Jalan
Padang Gajab, 45800
Jeram, Selangor Darul
Ehsan, Malaysia
M/s. Fresenius Kabi AG,
D-61346 Bad Homburg,
Germany
Natural Rubber Latex MaleCondom (Bulk)
31-1005-MD/2011-DC
MD-1005
15-03-2012
28-02-2015
BioR Filters
BioP Filters
31-1091-MD/2012-DC
MD-1091
16-03-2012
28-02-2015
M/s. Anteis SA, 18,
Chemin des Aulx, CH1228 Plan-lesOuates/Geneve,
Switzerland having
factory premises at M/s.
Chemic de I’Etraz 2, CH1027 Lonay,
VD/Switzerland
M/s. Zimmer Inc, 1800
West Center Street,
Warsaw IN, 46580, USA
SYNOLIS
31-1061-MD/2011-DC
MD-1061
20-03-2012
28-02-2015
Zimmer Natural Nail System
31-170-MD/2006-DC (Rereg. 2009) End 04
MD-170
4-04-2012
31-07-2012
M/s. Zimmer GmbH,
Sulzer Allee 8, CH-8404
Winterthur, Switzerland
Zimmer Natural Nail System
31-171-MD/2006-DC (Rereg. 2009) End 06
MD-171
4-04-2012
31-07-2012
12
61.
M/s. St. Jude Medical
India Private Limited, A &
B, 2nd Floor, “Brij Tarang”,
Greenlands, Begumpet,
Hyderabad-500016
M/s. Irvine Biomedical
Inc, 2375 Morse Venue,
Irvine, CA 92614, USA
62.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
63.
M/s. Orbusneich Medical
India Private Limited, no.
8, S.F. (208) Plot No. 16,
Rishabh Corporate Tower,
Community Centre,
Karkardooma, Delhi110092
M/s. Abbott Medical Optics
Private Limited, No. 91,
GNT Road, Madhavaram,
Chennai-600110
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537, USA
having factory premises
at M/s. Boston Scientific
Corporation, Two Scimed
Place Maple Grove, MN
55311-1566, USA
M/s. OrbusNeich medical
BV, Drs W.Van
Royenstraat 5, 3871 AN
Hoevelaken, The
Netherlands
64.
65.
M/s. 3M India Limited,
Survey No. 48/3 K.no.
927/912, 897
Hengasandra Village, 7th
Mile Hosur Road,
Bangalore-560068
M/s. Abbott Medical
Optics Inc, 1700 E. St.
Andrew Place, Santa
Ana, California 92705,
USA having factory
premises at M/s. AMO
Groningen BV, Van
Swietenlaan 5, 9728 NX
Groningen, The
Netherlands
M/s. 3M Health Care, St.
paul Minnesota 551441000, USA having factory
premises at M/s. 3M
Health Care, 3M
Brookings, 601, 22nd Ave.
Saffire Blu Duo Ablation
Catheter
Therapy Cool Path Ablation
Catheter
Therapy Cool Flex Ablation
Catheter
Promus Element Monorail
Everolimus-Eluting Coronary
Stent System
Taxus Element Monorail
Paclitaxel-Eluting Coronary
Stent System
31-23-MD/2006-DC (Rereg. 2009) End 01
MD-23
4-04-2012
30-06-2012
31-857-MD/2010-DC (End
02)
MD-857
4-04-2012
31-07-2014
Sapphire II Coronary Dilatation
Catheter
31-357-MD/2006-DC (Rereg. 2010) End 01
MD-357
4-04-2012
14-08-2013
Tecnis Toric 1-Piece Soft Acrylic
Lens
31-17-MD/2006-DC (ReReg. 2009) End 02
MD-17
4-04-2012
31-05-2013
3M Ioban 2 (Antimicrobial Incise
Drape)
31-874-MD/2010-DC (End
01)
MD-874
4-04-2012
15-11-2014
13
66.
67.
M/s. Smith & Nephew
Private Limited, Bldg 2-3 &
15-17 rajlaxmi Complex,
Opp. Hanuman Bus Stop,
Kalher, Thane-Bhiwandi
Road, Thane-421302
M/s. Johnson & Johnson
Limited, J—1 Shree
Arihant Complex, Village
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Bhiwandi
68.
M/s. Johnson & Johnson
Limited, J—1 Shree
Arihant Complex, Village
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Bhiwandi
69.
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal:Pardi (Valsad),
Gujarat
70.
M/s. Terumo Corporation,
South Brookings, South
Dakota 57006, USA
M/s. Smith & Nephew
Medial Limited, 101,
Hessle Road, Hull, HU3
2BN UK
M/s. Ethicon, EndoSurgery LLC, 475 Calle
C.Guaynabo, Puerto Rico
00969, USA having
factory premises at M/s.
Ethicon Endo-Surgery,
SA de CV Avenida De
Las Torres No. 7125,
Colonia Salvarcar 118,
Ciudad Juarez,
Chihuahua, 32580,
Mexico
M/s. Codman & Shurtleff
Inc, 325 Paramount
Drive, Raynham, MA
02767-0350 USA having
factory premises at M/s.
Cencert Medical LLC, 77
Accord Park Drive,
Norwell, MA 02061, USA
M/s. DePuy International
Limited, St. Anthony’s
Road, Leeds, LS11 8DT,
UK having factory
premises at M/s. DePuy
Orthopaedics Inc, 325
Paramount Drive,
Raynham, MA 02767,
USA
M/s. Terumo Europe NV,
Opsite Post-Operative Dressing
+ 14
31-969-MD/2011-DC (ReReg. 01)
MD-969
4-04-2012
30-04-2015
Valutrus-Circular Staples
Echelon-Endoscopic Linear
Cutter Reloads (Staples)
Contour-Curved Reloads
(Staples)
Endopath-Endoscopic Linear
Curved Cutter Reloads (Staples)
Proximate Linear Reloads
(Staples)
Ethicon-Endo Surgery ReloadsEndoscopic Linear Cutter
(Staples)
Agility Steerable Guidewires
Neuroscout Steerable
Guidewires
31-1054-MD/2011-DC
MD-1054
4-04-2012
28-02-2015
31-1047-MD/2011-DC
MD-1047
4-04-2012
28-02-2015
PFC Sigma RPF Knee System
31-668(A)-MD/2009-DC
(Re-reg. 2011)
MD-668(A)
4-04-2012
31-12-2015
K Pack II Needle
31-604-MD/2009-DC (End
MD-604
4-04-2012
31-05-2014
14
71.
72.
73.
74.
75.
76.
Alexander Square, 4th
Floor, 34 & 35, Sardar
Patel Road, Guindy,
Chennaio-600032
Researchpark Zone, 2Haasrode Interleuvenlaan
, 40, B-3001 Leuven,
Belgium
M/s. St. Jude Medical
India Private Limited,
Warehouse D. No. 8-3168/B/1/18 & 19, Laxmi
Nagar, MCH Circle-V,
Hyderabad-500038
M/s. Dynamesh Medical
India Private Limited,
“Dynamesh House”, 702,
7th Floor, Madhuban
Building, 55 Nehru Place,
new Delhi-110019
M/s. Vygon India Private
Limited, B-17, Sector-34,
Infocity, GurgaonM/s. St. Jude Medical
India Private Limited, No.
1-11-250/A, Mataranj
Sensation, Lane Besides
Syndicate bank,
Begumpet, Hyderabad500016
M/s. Elite Bio Medicals,
Krishan Plaza, 1st Floor,
37 Pratap Nagar, Mayur
Vihar-I, Delhi-110091
M/s. B. Braun Medical
India Private Limited,
prerna Complex, Bldg B,
Gala 1-10, Bhiwandi,
Thnane-421302
M/s. St. Jude Medical,
177 County Road B east,
St. Paul, MN-55117, USA
SJM Mechanical heart Valve
SJM Master Series (Rotatable)Aortic + 12
31-26-MD/2006-DC (ReReg. 02)
MD-26
4-04-2012
30-06-2015
M/s. FEG Textiltechnik
Forschungs Und
Entwicklingsgesellschaft
mbH, Julicher Str, 338a,
52070 Aachen, Germany
Surgical Meshes:-Dynamesh
Made up of polypropylene (PP)
Made up of Polyvinylidene
Fluoride
31-567-MD/2008-DC (ReReg. 01)
MD-567
18-04-2012
30-06-2015
M/s. Vygon SA, 5a 11,
rue, Adeline-95440
Ecouen, France
M/s. St. Jude Medical,
1350, Energy Lane St.
Paul, MN 55108, USA
Spinal Needles
Three Way Stopcocks
Extension Tube
Ensite Array Multi-electrode
Diagnostic catheter (EC 1000)
31-197-MD/2006-DC (Rereg. 2009) End 02
MD-197
18-04-2012
30-11-2012
31-27-MD/2006-DC (ReReg. 02)
MD-27
18-04-2012
30-06-2015
M/s. PNN Medical A/S,
Oldenvej 13, 3490
Kvistgaard, Denmark
Memokath 028, 044, 045, 051
(Urological Stent System)
31-781-MD/2010-DC
MD-781
18-04-2012
31-03-2015
M/s. B. Braun Melsungen
AG, carl-Braun-Str, 1
34212 Melsungen,
Germany having factory
premises at M/s. B. Braun
Melsungen AG, Aesculap
Division Vascular
Coroflex Blue Ultra Coronary
Stent System
Sequent II-PTCA catheter
31-687-MD/2009-DC (End
03)
MD-687
18-04-2012
30-11-2012
01)
15
77.
78.
M/s. B. Braun Medical
India Private Limited,
prerna Complex, Bldg B,
Gala 1-10, Bhiwandi,
Thnane-421302
M/s. Smith & Nephew
Healthcare Private
Limited, Building No. 2-3 &
15-17, Rajlaxmi Complex,
Opp. Hanuman Bus Stop,
Kalher, Thane Bhiwandi
Road, Dist-Thane-421302
79.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
80.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Palm Marg, Munirka, New
Delhi-110067
81.
M/s. Boston Scientific
India Private Limited, C-
Systems, Sieversufer 8,
12359 Berlin, Germany
M/s. B. Braun Surgical
SA, Carretera de
Terrassa, 121 08191
Rubi (Barcelona) Spain
M/s. Smith & Nephew Inc,
Endoscopy Division, 150
Minuteman Road,
Andover MA 01810, USA
having factory premises
at M/s. Smith & Nephew,
130 Forbes Boulevard,
Mansfield Massachusetts,
USA
M/s. Biosense Webster
Inc, 3333 Diamond
Canyon Road, Diamond
Bar, CA 91765, USA
having factory premises
at M/s. Biosense Webster
Inc, Circuito Interior Norte
# 1820, parquet Industrial
Salvacar, Juarez,
Chihuahua, Mexico
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
Massachusetts 17601537, USA having factory
premises at M/s. Boston
Scientific Corporation,
5905 Nathan Lane,
Plymouth, MN-55442,
USA
M/s. Boston Scientific
Corporation, One Boston
MonoMax-Absorbable
Monofilament Poly Sutures + 11
31-1093-MD/2012-DC
(Re-0Reg. 01)
MD-1093
18-04-2012
31-08-2015
Osteoraptor Suture Anchor with
Ultrabraid Suture
31-431-MD/2007-DC (ReReg. 2011) End 01
MD-431
18-04-2012
31-12-2014
Thermocool SF Catheter
31-119-MD/2006-DC (ReReg. 2009) End 02
MD-119
18-04-2012
31-05-2013
Adapt Monorail Carotid Stent
System
31-164-MD/2006-DC (ReReg. 2009) End 03
MD-164
18-04-2012
14-06-2013
Imager II Angiographic
Catheters
31-1069-MD/2011-DC
MD-1069
18-04-2012
31-03-2015
16
41, Ground Floor, Okhla
Industrial Area, Phase-II,
New Delhhi-110020
82.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Palm Marg, Munirka, New
Delhi-110067
83.
M/s. Apothecaries Private
Limited, 579, devil, East of
Sainik Farms, New Delhi110062
84.
M/s. Medicure Private
Limited, C-207, Jainam
Arcade, B T Mills
Compound, 2nd Floor, LBS
Marg, Bhandup (W),
Mumbai-400078
M/s. Medionic India
Private Limited, G-15,
basemant Kalkaji, New
Delhi-110019
85.
86.
M/s. Becton Dickinson
Scientific Place, Natick,
Massachusetts 17601537, USA having factory
premises at M/s. Teleflex
medical, Unit 7, 8 & 9
Annacotty Business Park,
Annacotty, County
Limerick, Ireland
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
Massachusetts 17601537, USA having factory
premises at M/s. Boston
Scientific Ireland Limited,
ballybrit Business Park,
galway, Ireland
M/s. Hoya Corporation, 27-5 Naka Ochiai,
Shinjuku-Ku, Tokyo 1618525, Japan Having
factory premises at M/s.
Hoya Medical Singapore
Pte Limited, 455A Jalan
Ahmed Ibrahim 639939
Singapore
M/s. Millennium
Biomedical Inc, 360 E.
Bonita Ave, Pomona CA
91767, USA
M/s. Medionic
International Inc, 114
Anderson Avenue,
Markham, Ontario L6E
1A5, Canada
M/s. Becton Dickinson
Wanda PTA Balloon Dilatation
Catheters
Wallstent Uni Endoprosthesis
with Unistep Plus Delivery
System
Mustang PTA Balloon Dilatation
Catheter
31-41A-MD/2006-DC (End
04)
MD-41A
18-04-2012
31-03-2013
HOYA iSert 250 Intraocular Lens
31-701-MD/2009-DC End
04
MD-701
18-04-2012
30-11-2012
PreciSAL Soft Hydrophobic
Acryclic Intraocular Lens
31-942-MD/2011-DC
MD-942
18-04-2012
31-03-2015
Peritoneal Dialysis Intraocular
Sets and Kits
31-238-MD/2006-DC (ReReg. 2009) End 01
MD-238
18-04-2012
31-05-2014
BD Spinal Needles
31-625-MD/2009-DC (re-
MD-625
18-04-2012
31-03-2015
17
87.
88.
89.
90.
91.
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Madhavaram,
Chennai-51
M/s. Becton Dickinson
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Madhavaram,
Chennai-51
SA, Camino de
Valdeoliva, S/v 28750
San Agustin del Guadalix,
Madrid-Spain
M/s. Becton Dickinson
SA, Ctra de at
Mequinenza s/n 22520
fraga, Huesca-Spain
M/s. Allergan Healthcare
India Private Limited, Shri
Arihant Comp. Bldg, No.
H-1 Gala No. 10, ThaneBhiwandi Road, DisttThane, Bhiwandi-421302
M/s. Intraocular Care
Private Limited, 26 Gandhi
Oil Mill Compound, Near
BIDC, Gorwa, Vadodara390016
M/s. Hitech Equipment N
System
53, Shahkar Socity, 25
Sector, Gandhinagar,
Gujarat
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal: Pardi (Valsad),
Gujarat
M/s. Allergan Route de
promery Zone Artisanale
de Pre Mairy, 74370,
Pringy, France
reg. 01)
Disposable Hypodermic Needles
Disposable Hypodermic
Syringes
Disposable Hypodermic
Syringes with needles
Auto Disable Syringes (Soloshot
IX)
2-Piece Syringes with breakable
plunger Solomed
2-Piece Syringes with Breakable
plunger solomed with needle
Hyaluronic Acid (Pre-filled
syringes)
Hyaluronic Acid with Lidocaine
(Pre-filled syringes)
31-1033-MD/2011-DC
(Re-Reg. 01)
MD-1033
18-04-2012
31-03-2015
31-483-MD/2008-DC (ReReg. 01)
MD-483
18-04-2012
31-05-2015
M/s. Hanita Lenses,
Kibutz Hanita, Israel
22885
Hydrophilic Intra Ocular Lenses
31-1084-MD/2012-DC
MD-1084
24-04-2012
31-03-2015
M/s. Dedienne-Sante,
Mas Des, Cavaliers-217
Rue Nungesser. F-34130
Mauguio, France
Knee Implants
Hip Implants
31-628-MD/2009-DC
MD-628
24-04-2012
31-03-2015
M/s. DePuy France SAS,
7 Allee Irene Joliot Curie,
BP 256, 69801, Saint
Priest Cedex, France
having factory premises
at M/s. DePuy Ireland
Loughbeg, Ringaskiddy
Corail AMT Cementless Femoral
Stems
31-*1068-MD/2011-DC
MD-1068
24-04-2012
31-03-2015
18
92.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
93.
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal: Pardi (Valsad),
Gujarat
94.
M/s. Synthes Medical
Private Limited, 118-P,
Sector-44, Gurgaon122002
M/s. Narang Entrepries, 1st
Floor, A-31, Kailash
Colony, New Delhi-110048
95.
96.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building No. 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri (E),
Mumbai-400093
97.
M/s. MED-EL India Private
Limited, #505, 5th Floor,
Co., Cork Ireland
M/s. DePuy Ireland
Loughbeg, Ringaskiddy
Co., Cork Ireland having
factory premises at M/s.
CreamTec GmbH,
Medical products
Division, CeramkTecPlatz 1-9, 73207
Plochingen, Germany
M/s. DePuy Ireland
Loughbeg, Ringaskiddy
Co., Cork Ireland having
factory premises at M/s.
Johnson & Johnson
Medial (Suzhou) Limited,
299 Chang Yang Street,
Suzhou Industrial Park,
Suzhou, China
M/s. Synthes GmbH,
Eimattstrasse 3, 4436
Oberdorf, Switzerland
M/s. Ophtec BV,
Schweitzerlaan 15, 9728
NR Groningen, The
Netherlands
M/s. Medtronic Inc, 710,
Medtronic Park Way, NE
Minneapolis MN-55432,
USA having factory
premise s at M/s. C.R.
Bard Inc, 289 Bay Road,
Qeuensbury, Ny 12804
USA
M/s. Vibrant MED-EL
Hearing technology
Delta Motion Modular Heads and
Modular Sleeves
31-1044-MD/2011-DC
MD-1044
24-04-2012
15-03-2015
Elite Plus Modular Heads
Duraloc Sector Cups
31-999-MD/2011-DC
MD-999
24-04-2012
31-03-2015
RapidSorb Resorbable Fixation
System consist of (1) Plates, (2)
Screws & Tacks
31-188-MD/2006-DC (Rereg. 2009) End 02
MD-188
24-04-2012
30-11-2012
Hydrophilic Acrylic Intraocular
Lnes (Foldable Intraocular Lens
inclusive of Dualtec Kit &
Cartridge)
PMMA Intraocular Lens
Angiography Guide Wires
Woven Angiographic Catheter
31-436-MD/2008-DC (ReReg. 01)
MD-436
24-04-2012
31-03-2015
31-341-MD/2007-DC (Rereg. 2010) End 01
MD-341
25-04-2012
14-08-2013
Vibrant Soundbridge Implantable
Hearing Prosthesis System
31-599-MD/2008-DC (Rereg. 01)_
MD-599
25-04-2012
15-04-2015
19
98.
99.
100.
101.
Pragati House, 47-48,
Nehru Place, New Delhi110019
M/s. Becton Dickinson
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Madhavaram,
Chennai-51
M/s. Meditech Devices, 8,
Devam Second Floor,
Indranil Society, Nr. Jivraj
Cross Road, Vejalpue,
Ahmedabad-380051
M/s. Vascular Solutions
India Private Limited, B206 Everest Grande,
mahakali caves Road,
Opp. Ahura Centre,
Andheri (E), Mumbai400093
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
GmbH, Furstenweg 77,
Innsbruck, A-6020 Austria
M/s. Becton Dickinson
Infusion Therapy
Systems Inc, 9450 SouthState Street, Sandy, Utah
84070, USA
M/s. Foshan Nanhai
Baihe Medical
Technology Co. Limited,
Technology Garden,
taoyuan West Road,
Shishan Nanhai, Foshan
Guyangdong Province
P.R. China 528225
having factory premises
at M/s. no. 14, Haier
Road, Guicheng Nanhai
District Foshan City
Guang Dong Province
P.R. China-528200
M/s. Qualimed Innovative
Medizinprodukte GmbH,
Boschstrasse 16, D21423 Winsen, Germany
M/s. Boston Scientific
Corporation, One Boston
Scientific Place Natick,
Massachusetts 017601537, USA having factory
premises at M/s. Boston
Scientific Cork Limited,
Business and Technology
Park, Model Farm Road,
BD Q-Syte (Luer Access Split
Septum)
31-84-MD/2006-DC (ReReg. 02)
MD-84
25-04-2012
30-09-2015
Hemodialysis Catheter
31-805(c )-MD/2010-DC
MD-805(C
)
3-05-2012
15-04-2015
Pyxis-C-PTCA Balloon catheter
(PC)
Curvus-Stent Delivery System
(CS)
VMAX-Aspiration Catheter (VX)
CURSA-Stetn Delivery System
(CA)
Renegade Hi-Flo Microcatheter
Extractor Pro XL Stone retrieval
Balloon Catheter
Extractor Pro RX Stone retrieval
Balloon catheter
Extractor Pro DL Stone retrieval
Balloon catheter
31-1014-MD/2011-DC
MD-1014
3-05-2012
15-04-2015
31-163-MD/2006-DC (ReReg. 09) End 01
MD-163
3-05-2012
31-03-2013
20
102.
M/s. Bausch & Lomb
Eyecare India Private
Limited, Plot No. 13,
Sector-34, Gurgaon
103.
M/s. Biotronik Medical
Devices India Private
Limited, 101-106, Plot No.
14, LSC Kalkaji, New
Delhi-110019
M/s. B. Braun Medical
India Private Limited, Bldg
No. B, Gala No. 1-10,
Prerna Complex, Anjur
Phata Dapoda Road, At
Val Village Bhiwandi421302
M/s Cochlear Medical
Device Company India
Pvt. Ltd., Unit No. G-3,
Ground Floor, Platina
Building, CTS No. 4207C59, G Block, Bandra Kurla
Complex, Bandra (East),
Mumbai, Tal: Bandra East
Mumbai-400051.
104.
105.
106.
M/s Cochlear Medical
Device Medical Company
Cork, Ireland
M/s. Bausch & Lomb
Incorporated, 30
Enterprises, Suite 450,
Aliso Viejo, California
92656 USA having
factory premises at M/s.
Bausch & Lomb
Incorporated, 10574
Acacia Street, Suite D-1,
Rancho Cucamonga, CA
91730
M/s. Biotronik AG,
Ackerstasse 6, 8180
Bulach, Switzerland
M/s. Proxy Biomedical
Limited, Coileach,
Spiddal, Co Galway,
Ireland
M/s Cochlear Ltd, having
factory premises at 14
Mars Road, Lane Cove
NSW 2066 Australia
M/s Cochlear Bone
Anchored Solution AB
Crystalens Accommodating
Intraocular Lens
31-610-MD/2009-DC (ReReg. 01)
MD-610
3-05-2012
15-04-2015
Orsiro Sirolimus Eluting
Coronary Stent System
31-461-MD/2008-DC (ReReg. 2010) End 02
MD-461
3-05-2012
30-04-2014
Omyra Mesh
31-979-MD/2011-DC
MD-979
3-05-2012
31-03-2015
31-81-MD/06-DC (Re-reg
2009)
MD-81
3-05-2012
15-04-2015
31-80-MD/2006-DC (Rereg 2009)
MD-80
3-05-2012
15-04-2015
1. Cochlear Hybrid System
2. Cochlear ™ Nucleus® 5
System
3. Nucleus® Freedom
Cochlear Implant
System
4. Nucleus® 3 System
Cochlear Implant
System
5. Nucleus® 24 Auditory
Brainstem Implant (ABI
24M) System
1. BAHA SYSTEM
2. COCHLEAR BAHA BP
21
107.
108.
109.
110.
India Pvt. Ltd., Unit No. G3, Ground Floor, Platina
Building, CTS No. 4207C59, G Block, Bandra Kurla
Complex, Bandra (EAST),
Mumbai, Tal: Bandra East
Mumbai-400051
M/s. B. Braun Medical
India Private Limited, 5th
Floor, East Quadrant, The
IL & FS Financial Centre,
Bandra Kurla Complex,
Bandra (E), Mumbai400051
M/s. B. Braun Medical
India Private Limited, 5th
Floor, East Quadrant, The
IL & FS Financial Centre,
Bandra Kurla Complex,
Bandra (E), Mumbai400051
M/s. Organon India Private
Limited, Gala No. 1-C,
Bldg No. B-3, City Link,
Warehousing Com.
Mumbai Nashik Highway,
Vapada, Tal Bhiwandi
Dist-TH, Tal: Bhiwandi
M/s. Nipro India
Corporation Private
Limited, New No. 167, Old
No. 137, Yasdee House,
1st Floor, Valluvarkottam
High Road, Chennai600034
having factory premises
at Konstruktion S vagen
14 SE 43533 Molnlycke,
Sweden
100
M/s. B. Braun Melsungen
AG, Carl-Braun Str, 1,
34212 Melsungen,
Germany having factory
premises at M/s. B. Braun
Medical AG, Hauptstrabe
39, 6182 Escholzmatt,
Switzerland
M/s. B. Braun Melsungen
AG, Carl-Braun Str, 1,
34212 Melsungen,
Germany
Original Perfusor Syringe 50 ml
31-659-MD/2009-DC(End
02)
MD-659
24-04-2012
31-07-2012
Perifix/Perific Paed (Catheter for
Epidural Anaesthesia)
31-146-MD/2006-DC (reReg. 09) End 01
MD-146
3-05-2012
31-11-2012
M/s. Nanjing Organon
Pharmaceutical Co.
Limited, Pukou High-Tech
development Zone, PO
Box 3209-27, Nanjing210061, The Republic of
China
M/s. Nipro Corporation, 39-3, Honjo Nishi Kita Ku,
Osaka 531-8510, Japan
having factory premises
at M/s. Nipro Corporation
Limited, 10/2 Moo 8,
Bangnomko, Sena Phra,
Nakhon Si Ayutthaya
13110, Thailand
Cu-250 & Cu-375 radio opaque,
Intra Uterine Contraceptive
Device
31-1042-MD/2012-DC
MD-1042
8-05-2012
15-04-2015
Tubing set for Hemodialysis
Arterial Venous Fistula Needle
set (AVF set)
Pediatric Scalp Vein needle set
(PSV set)
Disposable Hypodermic Needles
Disposable Syringes without
needles
Disposable syringes with
31-1115-MD/2012-DC
MD-1115
8-05-2012
15-04-2015
22
111.
112.
113.
M/s. Surgicon Healthcare
Private Limited, 611-612,
Sakar-V, B/H Natraj
Cinema, Ashram Road,
Ahmedabad-380009
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill, Khaler,
Thane-Bhiwandi Road,
Distt-Thane, Bhiwandi
M/s. Croma Pharma
Gesellschaft m.b.H.
Industriezeile 6, A-2100
Leobendorf, Austria
M/s. Synthes Medical
Private Limited, Plot No.
118-P, Sector-44,
Gurgaon-122002
M/s. Synthes GmbH,
Eimattstrasse 3, 4436
Oberdorf, Switzerland
M/s. Cordis Europa N.V.
Oosteinde 8, 9301 LJ
Roden, Netherlands
having factory premises
at M/s. Cordis de Mexico,
SA de C.V. calle Circuito
Interior Norte #1820,
Parque Industrial
Slavarcar, Ciudad Juarez,
Chihuahua, Mexico
92575
needles
Visicrom 2% Hydroxypropyl
methylcellulose in disposable
glass syringes + 4
Duara Star RX PTCA Dilatation
Catheter
Fire Star RX PTCA Dilatation
Catheter
Crodis Palmaz Blue 0.14
Peripheral Stent System
Corids Palmaz Genesis
Peripheral Stent on OPTA PRO
.035 delivery System
Cordis Palmaz Blue .018
Peripheral Stent System
Opta Por Percutaneous
Transluminal Angioplasty (PTA)
balloon Dilatation Catheter
Powerflex Extreme
Percutaneous Transluminal
Angioplasty (PTA) Balloon
Dilatation Catheter
Maxi LD Percutaneous
Tranluminal Angioplasty (PTA)
Balloon Dilatation Cathter
Crodis Aviator Plus
Percuraneous Transluminal
Angioplasty (PTA) Balloon
Dilatation Catheter
SAVVY Percutaneous
Transluminal Angioplasty (PTA)
Balloon Dilatation catheter
Dynamic Locking Screw System
Norian Drillable Bone Void Filler
31-978-MD/2011-DC
MD-978
8-05-2012
15-04-2015
31-116-MD/2006-DC (ReReg. 02)
MD-116
8-05-2012
31-07-2015
31-188-MD/2006-DC (ReReg. 09) End 02
MD-188
8-05-2012
30-11-2012
23
114.
M/s Atrium Medical India
Pvt.Ltd., Old No. 54, New
No. 11, NRD Tower, 3rd
Floor, First Avenue,
Jawaharlal Nehru Road,
Ashok Nagar, Chennai600 083.
M/s Atrium Medical
Corporation having
factory premises at 5,
Wentworth Drive Hudson,
New Hampshire 03051,
USA
115.
M/s Organon (India)
Private Limited, Gala No.
1-C, Bldg. No. B-3, City
Link, Warehousin Com.
Mumbai Nashik Highway,
Vadapa, Tal Bhiwandi
Dist-TH, Tal: Bhiwandi
(Thane-Zones).
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
02, 100 Shed Area, GIDC,
Vapi, Tal-Pardi
M/s Nanjing Organon
Pharmaceutical Co.
Limited, having factory
premises at Pukou HighTech Development Zone,
P.O Box 3209-27,
Nanjing-210061 The
Republic Of China
M/s. Depuy International
Limited, St. Anthony’s
Road, Leeds, UK LS 11
8DT having factory
premises at M/s. Depuy
(Ireland) Loughbeg,
Ringaskiddy, Cork,
Ireland
M/s. Depuy International
Limited, St. Anthony’s
Road, Leeds, UK LS 11
8DT having factory
premises at M/s. Depuy
(Ireland) Loughbeg
Ringaskiddy, Cork,
116.
117.
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
02, 100 Shed Area, GIDC,
Vapi Tal-Pardi
1. Family of C-Qur
Mesh
2. Family of Advanta
Grafts
3. Advanta V12 PTEF
Stent Graft System.
4. ClearWay RX
Catheter
5. ICAST Covered
Stent
6. IVENA Vascular
Patch
7. Family Of
Polypropylene
Monofilament
Surgical Mesh
1. Cu-250 & Cu-375 radio
opaque, Intra Uterine
Contraceptive device
31-524-MD/2008-DC (Rereg 2011)
MD-524
8-05-2012
15-04-2015
31-1042-MD/2012-DC
MD-1042
8-05-2012
15-04-2015
Sigma CR-15 Orthopaedic Knee
Implant
31-674-MD/2009-DC (ReReg. 01)
MD-674
14-05-2012
14-01-2016
Sigma CR-15 Orthopaedic Knee
Implant
31-674-MD/2009-DC (ReReg. 01)
MD-674
14-05-2012
14-01-2016
24
Ireland
M/s. Oscor Inc, 3816
DeSoto Boulevard, Palm
Harbor, FL 34683 USA
118.
M/s. B. L. Lifesciences
Private Limited, A-245
Okhla Industrial Area,
Phase-I, New Delhi110020
119.
M/s. Johnson & Johnson
Limited, Shed No. A1/50,
100 Shed Area, Degam
Road, GIDC, Vapi-396195
M/s. Zimmer India Private
Limited, Plot No. B & B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
M/s. DePuy Ireland,
Loughbeg, Ringakiddy
Co. Cork Ireland
121.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
122.
M/s. St. Jude Medical
India Private Limited, D.
No. 8-3-168/B/1, Plot No.
18 & 19, Laxmi Nagar,
Behind T.B. Hospital, MCH
Circle-5, Mandal,
Hyderabad
M/s. Elder
Pharmaceuticals Limited,
“Eleder House”, C-9 Dalia
120.
123.
Occlusion balloon Catheter
TME Temporary Myocardial
Heartwires Unipolar, Bipolar,
Quadripolar
Introducer Sets
Angios-Angiographic Catheter
(Non-Sterile_)
Pinnacle Hip System-M-Spec
Heads & Acetabular Inserts
Modular-Femoral Heads-Ultamet
31-982-MD/2011-DC
31-982
12-06-2012
30-04-2015
31-1003-MD/2011-DC
MD-1003
12-06-2012
30-04-2015
M/s. Zimmer Inc, 1800
West Center Street,
Warsaw, Indiana 46580,
USA
Longevity Highly Crosslinked
Polyethylene Elevated Rim Liner
31-170-MD/2006-DC (ReReg. 2009) End 07
MD-170
12-06-2012
31-07-2012
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537, USA
having factory premises
at M/s. Boston Scientific
Corporation, Two Scimed
Place Maple Grove, MN
55311-1566, USA
M/s. St. Jude Medical
Atrial Fibrillation Inc,
14901 DeVeau Place,
Minnetonka, MN 553452126, USA
NC Quantum Apex Monorail
PTCA Dilatation Catheter + 5
31-857-MD/2010-DC (End
01)
MD-857
12-06-2012
31-07-2014
Livewire Steerable
Electrophysiology CathetersBDB/CSL/Spiral HP + 11
31-22-MD/2006-DC (ReReg. 02)
MD-22
12-06-2012
30-06-2015
M/s. PFM Medical
Titanium GmbH,
Hoefener Strasse 45, D-
TiMESH Surgical Mesh
31-323-MD/2007-DC (Rereg. 010
MD-323
12-06-2012
15-05-2015
25
124.
125.
126.
Industrial Estate, Off
Veera Desai Road,
Taluka-Andheri, Andheri
(W), Mumbai-400058
M/s. Vascular Concepts
Limited, 7C,
Doddaballapur Industrial
Estate, Doddaballapur,
Banglaore-561203
M/s. Covidien Healthcare
India Private Limited,
“Doshi Tower”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Emergo India
Consulting Private Limited,
H. no. 8/1, 1st Floor,
Vasavi Colony, Kakaguda,
Near Picket,
Secunderabad, MCH
Circle-7 Mandal,
Hyderabad-500009
90431 Nuremberg,
Germany
M/s. Eucatech AG,
Gottlieb-Daimler-Str-2, D79618 Rheinfelden,
Germany
Prolink-LP-Coronary Stent
System (Non-Sterile) + 11
31-03-MD/2006-DC (rereg. 09) End 01
MD-03
12-06-2012
28-02-2015
M/s. Covidien IIc, 15
Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s. Covidien
Zone Franca de San
Isidro Santo Domingo,
Dominican Republic
M/s. Navilyst Medical Inc,
26 Forest St.
Marlborough MA 01752,
USA having factory
premises at M/s. Navilyst
Medical inc, 10 Glens
Falls Technical Park
Glens Falls, NY 12801,
USA
Appose ULC Auto Suture Slim
Body Skin Reload (Staples)
31-948-MD/2011-DC (End
020
MD-948
12-06-2012
14-04-2014
Namic Angiographic/Radiology
Control Syringes
Angiographic Guidewires
Namic Closed Fluid Systems
Namic Angiographic Manifold
Xcela Power Injectable
PICC/Xcela PICC with PASV
valve Technology Catheter
Kits/MST Kits/IR Kits
Vaxcel Plus Chronic Dialysis
Catheters, vaxcel PICC with
PASV Valve technology
Catheter Kits/Peelable
Introducer Kits/MSAT Kits/IR
Kits
PASV Ports
Vaxcel Mini-Stick Vascular Entry
System-Coaxial Entry Kits &
Peelable Entry Kits/Insertion Kits
Exodus Drainage catheters
(Multipurpose/Nephrostomy/Bilia
ry)
31-992-MD/2011-DC
MD-992
13-6-2012
30-04-2015
26
127.
128.
129.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
130.
M/s. Boston Scientific
India Private Limited, C41, Ground Floor, Okhla
Industrial Area, Phase-II,
New Delhi-110020
131.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Palme Marg, Munirka, new
Delhi-110067
M/s. ev3 Inc, 4600
Nathan Lane North,
Polymouth, MN 55442,
USA
TrailBlazer Support Catheter
31-51-MD/2006-DC (Rereg. 2011) End 02
MD-51
13-6-2012
31-03-2014
M/s. Micro Therapeutics
Inc, d/b/a/ev3
Neurovascular, 9775
Tolego Way, Irvine CA
92618, USA
Apollo Onyx Delivery Micro
Catheter
Solitaire FR Revascularization
Device
31-51A-MD/2006-DC (ReReg. 2011) End 01
MD-51A
13-6-2012
14-05-2014
M/s. ev3 Inc, 4600
Nathan Lane North,
Polymouth, MN 55442,
USA having factory
premises at M/s. Micro
Therapeutics Inc,
d/b/a/ev3 Neurovascular,
9775 Tolego Way, Irvine
CA 92618, USA
M/s. Boston Scientific
Corporation, One Boston
Scientific Place Natick,
MA 01760-1537, USA
having factory premises
at M/s. Boston Scientific
Corporation, 2546 First
Street, Propark, EI Coyol,
Alajuela, Costa Rica
M/s. Boston Scientific
Corporation, One Boston
Scientific Place Natick,
MA 01760-1537, USA
having factory premises
at M/s. Boston Scientific
Ireland Limited, ballybrit
Business Park, Galway,
TurboHawk Peripheral Plaque
Excision System
31-624-MD/2009-DC (ReReg. 2011) End 02
MD-624
13-6-2012
31-03-2014
Dreamwire High Performance
Guidewires
Hydra-Jagwire Guidewires
Single Use Guidewires
Zebra Urological Guidewires
Magic Torque Guidewires
Platinum Plus Guidewires
31-1037-MD/2011-DC
MD-1037
13-6-2012
15-05-2015
Taxus Liberte Paclitaxel Eluting
Coronary Stent System
Apex Monorail PTCA Dilatation
catheter
Maverick 2 Monorail PTCA
Dilation Catheter
31-41A-MD/2006-DC (ReReg. 21009) End 06
MD-41A
13-6-2012
31-03-2013
27
132.
133.
134.
135.
136.
137.
138.
139.
140.
M/s. Faith Biotech Private
Limited, E-107, Lajpat
Nagar, New delhi-110024
M/s. Sivagami Commercial
Co. Private Lilmited,
Ground Floor, New No.
202, Old No. 742, Anna
Salai, Chennai-600002
M/s. becton Dickinson
India Private Lilmited, No.
34, Assisi Nagar, West
Thottam, Modhavaram,
Chennai-51
M/s. Baxter India Private
Limited, Plot No. 70, A-26,
Rama Road Industrial
Area, New Delhi-110015
M/s. Zimmer India Private
Limited, Plot No. B & B1,
vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
M/s. Allergan Healthcare
India Private Limited,
Level 2, Presige Obelisk
No. 3, Kasturba Road,
Bangalore-560001
M/s. Synthes Medical
Private Limited, Plot No.
118P, Sector-44, Gurgaon
M/s. Amardeep
Enterprises, No. 5-6, 3rd
Floor, nr. Income Tax
Building, Ashram Road,
Ahmedabad-380009
M/s. venus Medical
Ireland
M/s. Bioster, a.s. Tejny
621, 664, 71, Veverska
Bityska, Czech Republic
M/s. lBioretec Limited,
Hermiankatu 22,
Modulight Building, FI33720, Tampere, Finland
Traumastem Taf
31-525-MD/2008-DC (rereg. 20110
MD-525
13-6-2012
15-05-2015
Orthopaedic Implant: Biotetec
Activa Pin and Activa Screw
31-570-MD/2008-DC (ReReg. 01)
MD-570
13-6-2012
30-04-2015
M/s. becton Dickinson
SA, Ctra de Mequinenza
s/n 22520 Fraga,
Huesca-Spain
BD Soloshot Mini Auto-Disable
Syringes
31-1033-MD/2011-DC
(End 01)
MD-1033
13-6-2012
31-03-2015
M/s. Baxter Healthcare
SA, Foxford Road
Swinford, County Mayo
Ireland
M/s. Zimmer Trabecular
Metal technology Inc, 10
Pomeroy Road,
Parsippany, New Jersy
07054
2pc. Titanium adapter (5C4129)
31-734-MD/2009-Dc
MD-734
13-6-2012
15-05-2015
Trabecular Metal Glenoid, for the
Bigliani/Flatow Complete
Shoulder System
31-594-MD/2009-DC (Rereg. 2011) End 01
MD-594
13-6-2012
31-01-2015
M/s. Allergan, Route de
Promery Zone, Artisanale
de Pre Mairy, 74370
Pringy, France
Hyaluronic Acid with Lidocaine
31-483-MD/2008-DC (End
02)
MD-483
13-6-2012
31-05-2012
M/s. Synthes GmbH,
Eimattstasse 3, CH-4436,
Oberdorf, Switzerland
M/s. Solco Bio-medical
Co. Limited, 34-6,
Keumam-ri, Seotanmyeon, Pyengtaek,
Gyeonggi-do, Korea
M/s. Lanstec (Barbados)
Angular Stable Locking Screw
System (ASLS)
31-188-MD/2006-DC (ReReg. 2009) End 07
MD-188
13-6-2012
30-11-2012
4CIS Apollon Spine System
(Non Sterile)
31-383-MD/2007-DC (ReReg. 2011) End 01
MD-383
13-6-2012
31-07-2014
Intraocular Lenses
31-1111-MD/2012-DC
MD-1111
13-6-2012
30-04-2015
28
141.
142.
143.
144.
145.
Products, 423, Sant
Nagar, east of Kailash,
New delhi-65
Inc, Airport Commercial
Centre, Pilgrim Road,
Christ Chruch BB 17092
M/s. Paul Hartmann
Medical Private Limited, A201, Dynasty Building, 2nd
Floor, Regus Business
Park, Andheri Kular Road,
Andheri (E), Mumbai400059
M/s. Paul Hartmann
Medical Private Limited, A201, Dynasty Building, 2nd
Floor, Regus Business
Park, Andheri Kular Road,
Andheri (E), Mumbai400059
M/s. Paul Hartmann AG,
Paul-Hartmann-Strabe
12, D-89522 Heidenheim,
Germany having factory
premises at M/s. Paul
hartmann SA 08302
Mataro Spain
M/s. Paul Hartmann AG,
Paul-Hartmann-Strabe
12, D-89522 Heidenheim,
Germany having factory
premises at M/s.
Hartmann Rico a.s.,
Chavalkovice 125, 55204
Chvalkovice Czech
republic
M/s Heraeus Medical
GmbH, Philipp-Reis-Str.
8/13, 61273 Wehrheim,
Germany
M/s. Heraeus
Technologies India Pvt.
Ltd., 370/20 GF-Shanti
Nagar Near Rajiv Chowk,
NH-8, Distt. Gurgaon 122001
M/s Teleflex Medical Pvt.
Ltd, Old No. 10, No. 19, 1st
Floor & Ground Floor,
Harrington Road, Chetpet
Chennai-600031
M/s. Abbott Healthcare
M/s. Abbott Vascular,
Softec-PS-spherie Posterior
Chamber Intraocular Lenses
Softec-HD-Aspheric Posterior
Chamber Intraocular Lenses
Cosmopor E (Sterile)
Omnifix E
Safix Plus (Plaster of Paris
Bandages)
1. Bone Cement
2. Bone Cement with
Gentamycin
1. Percutaneous
Tracheostomy Tube
(PercuQuick® Set –
Cat# 121549,
Percuquick – Cat#
121550, Percutwist Set
– Cat# 121555)
2. Suprapubic Cystostomy
Set (Easycyst
Polyurethane Cat#
170718)
Xience SBA Everolimus Eluting
31-952-MD/2011-DC
MD-952
13-6-2012
15-05-2015
31-954-MD/2011-DC
MD-954
13-6-2012
30-04-2015
31-376-MD/2007-DC (Rereg. 2010)
MD-376
13-6-2012
30-04-2015
31-851-MD/2010-DC
(End.01)
MD-851
13-6-2012
31-7-2014
31-307-MD/2007-DC (Re-
MD-307
28-6-2012
30-06-2013
29
Private Limited, 4
Corporate Park, Sion
Tromaby Road, Chembur,
Mumbai-400071
146.
147.
148.
149.
M/s. Kirloskar
Technologies Private
Limited, D-97-98, Ground
Floor, Lajpat Nagar Part-1,
New Delhi-110024
M/s. Synthes Medical
Private Limited, Plot No.
118-P, Sector-44,
Gurgaon
M/s. St. Jude Medical
India Private Limited, Plot
No. 18 & 19, Laxminagar,
Behind T.B. Hospital,
Hyderabad-500038
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC
Vapi, Tl-Pardi
3200 Lakeside Drive,
Santa Clara California
95054, USA having
factory premises at M/s.
Abbott Vascular, 26531
Ynez Road, Temecula,
California 92591, USA
M/s. InspireMD Limited, 3
Menorat Hamaor St. Tel
Aviv 67448, Israel
Coronary Stent System
Reg. 10) End 01
Coronary Stent System MGuard
31-1137-MD/2012-Dc
MD-1137
28-6-2012
14-06-2015
M/s. Synthes GmbH,
Eimattstrasse 3, 4436
Oberdorf, Switzerland
Prodisc (-C Nova) non fusion
devices (Modular intercertabral
disc prosthesis)
Zero-PVA (Spine Implant Sterile)
Pacel Bipolar Pacing Catheter
Angio-Seal Vascular Closure
Deviuce
Fast-Cath Hemostasis
Introducer
GuideRight Guidewires
Luer Cap, Hemostais Valve
adapter, Vassel Dilator,
Pepositioning Sleeva, Sheath
Obturator, Contamination
Cover/Protective Cap
Engage Introducer
Orthocord Suture with or without
Needles
31-188-MD/2006-DC (Rereg. 2009
MD-188
28-6-2012
30-11-2012
31-22-MD/2006-DC (Rereg. 02)
MD-22
28-6-2012
30-06-2015
31-1051-MD/2011-Dc
MD-1051
28-6-2012
31-05-2015
M/s. St. Jude Medical,
14901 DeVeau Place,
Minnetonka, MN-553452126
M/s. DePuy Mitek, A
Johnson & Johnson
Com., 325 Paramount
Drive, Raynham,
Massachusetts 02767,
USA having factory
premise at M/s. Ethicon
Inc, 3348 Pulliam Street,
San, Angelo, Texas,
76905, USA
30
150.
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC
Vapi, Tl-Pardi
151.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
Distt-Thane
152.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
Distt-Thane
153.
M/s. Chennai Medipoint
Private Limited, B/III/7,
Parsn Manere, 602, Anna
Salai, Chennai-600006
154.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Tower”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. DePuy Mitek, 325
Paramount Drive,
Raynham, Massachusetts
02767, USA having
factory premise at M/s.
DePuy Mitek SARL Rue
du Puits Godet 20,
Neuchatel, CH-2000,
Switzerland
M/s. Codman & Shurtleff
Inc, 325, Paramount
Drive, Raynham
Massachusetts, USA
having factory premises
at M/s. Lake Region
Medical, 340 lake
Hazeltine Drive, Chaska,
MN-55318, USA
M/s. Johnson & Johnson
do Brasil Industria E
Comercio De Produtos,
Para Saude Ltda,
Rodovia Presidente Dutra
Km 154, Sao Jose dos
Campos Sao Paulo,
Brasil CEP-12240-908
M/s. Nicast Ltd, 2 Yodfat
St. 71291 Lod, Israel
M/s. Micro Therapeutics
Inc, d/b/a eV3
Neurovascular, 9775
Toledo Way, Irvine CA
92618, USA
Sterile Metallic Anchors
Sterile Bio Anchors
Sterile Bio Interference Screws
Sterile Metallic Screws
Gryphon Anchor System
Omnispan Meniscal Repair
System
31-1141-MD/2012-DC
MD-1141
4-7-2012
31-10-2015
Enterprise Vascular
Reconstruction Device and
Delivery System
31-706-MD/2009-DC (ReReg. 01)
MD-706
4-7-2012
31-12-2015
Caprofyl Absorbable Surgical
Sutures
31-1073-MD/2011-DC
(Re-Reg. 01)
MD-1073
4-7-2012
31-08-2015
AV flo Vascular access graft,
straight Configurations
AV flo Vascular access graft,
centered Coil Configuration
AV flow Vascular access graft,
Off-centered Coil Configuration
Nautica Micro Catheter
Rebar Micro catheter
Syringes
31-1027-MD/2011-DC
MD-1027
4-7-2012
15-06-2015
31-51A-MD/2006-DC (Rereg. 2011) End 03
MD-51A
4-7-2012
14-05-2014
31
155.
M/s. B. Braun Medical
India Private Limited, Blog
No. B, Gala No. 1-10,
Prerna Complex, Anjur
Phata, Dapoda Road, At
Val Village Bhiwandi421302
156.
M/s. St. Jude Medical
India Private Limited, A &
B, 2nd Floor, Brij Tarang,
greenlands Begumpet,
Hyderabad-500006
157.
M/s. Carl Zeiss India
Private Limited, 22
Kanisngton Road, Ulsoor,
Bangalore-560008
158.
M/s. Becton Dickinson
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Madhavaram,
Chennai-51
M/s. Becton Dickinson
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Madhavaram,
Chennai-51
159.
M/s. B. Braun Melsungen
AG, Carl-Braun-Str., 1,
34212 Melsungen,
Germany having factory
premises at M/s. B. Braun
Medical AG, Hauptstrabe
39, 6182 Escholzmatt,
Switzerland
M/s. St. Jude Medical
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar 91342, USA
M/s. Carl Zeiss Meditec
SAS, Avenue Paul
Langevin-BP 5, 17053 LA
Rochella Cedex 9 France
having factory premises
at M/s. Carl Zeiss
Meditec SAS 27 Avenue
Paul Lengevin 17180
Perigy France
M/s. becton Dickinson
Medical (Singapore) Pte
Limited, 30, Tuas Avenue
2, Singapore 639461
M/s. Becton Dickinson
Medical-Diabetes Care, 1
becton Drive, Franklin
Lakes, new Jersy USA
07417 having factory
premises at M/s. Becton
Dickinson & Co., Pottery
Road Dun Laoghaire Co
Discofix
Omnifix
31-659-MD/2009-DC (ReReg. 01)
MD-659
4-7-2012
31-07-2015
Fortify Family of Implantable
Cardioverter Defibrillators
Unify Family of Cardiac
Resynchronization Therapy
Defibrillators
Promote Quadra Family of
Cardiac Resynchronization
Therapy Defibrillators
Intraocular Lens CT Asphina
409M
Intraocular Lens CT Asphina
509M
31-300-MD/2007-DC (Rereg. 2010) End 02
MD-300
4-7-2012
14-09-2013
31-148-MD/2009-DC (End
01)
MD-148
4-7-2012
31-01-2013
BD Hypoint Needles
31-1032-MD/2011-DC
(End 010
MD-1032
4-7-2012
12-03-2015
Pen Needles
31-707-MD/2010-DC (ReReg. 01)
MD-707
4-7-2012
14-01-2016
32
160.
161.
162.
163.
164.
165.
M/s. Paul hartmann
Medical Private Lilmited,
A-201 Dynasty Building,
2nd Floor, Regus Business
Park, Andheri Kurla Road,
Andheri East, Mumbai400059
M/s. Zimmer India Private
Limited, Plot No. B & B1,
vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
M/s. Zimmer India Private
Limited, Plot No. B & B1,
vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
M/s. Johnson & Johnson
Limited, A-1/50, Room no.
2, 100 Shed Area, GIDC,
vapi, Taluka Pardi District,
Valsad
M/s. Intas Medi Devices
Limited, 7th Floor, premier
House-I, S.G. Highway,
Ahmedabad-380054
M/s. Synthes Medical
private Limited, No. 118-P,
Dublin, Ireland
M/s. Paul Hartmann AG,
Paul hartmann Str-12
89522 Heidenheim,
Germany
Atrauman AG
HydroColl
HydroColl Thin
31-956-MD/2011-Dc
MD-956
11-7-2012
15-06-2015
M/s. Zimmer Spine, Cite
Mondiale, 23, Parvis des
Chartrons, 33080
Bordeaux, France
Fidji Cervical Interbody Implants
Fidji Lombaire-Interbody
Implants
Universal Clamp-Spinal
Osteosynthesis Implants
Uni Wallis-Non Fusion Implant
Instant Java System-Spinal
Osteosynthesis Implants
31-1043-MD/2011-DC
MD-1043
11-7-2012
15-06-2015
M/s. Zimmer Inc, 1800
West Center Street,
Warsaw IN 46580, USA
Zimmer Trabecular Metal
Reverse Shoulder System
31-170-MD/2006-DC (Rereg. 2009) End 06
MD-170
11-7-2012
31-07-2012
M/s. DePuy Orthopaedics
Inc, 700 Orthopaedic
Drive, Warsaw, Indiana
46581-0988, USA
Duraloc Acetabular Cup System
+ 15
31-127-MD/2006-DC (ReReg. 02)
MD-127
11-7-2012
30-11-2015
M/s. Alvimedica Tibbi
Urunler San Ve Dis. Tic.
A.S. Istanbul Trakya,
Serhest Bolgesi
Ferhatpasa Mahallesi
Ataturk Bulvari Manolya,
Sokak No. 7 Catalca,
Istanbul, Turkey
M/s. Synthes GmbH,
Eimattstrasse 3, 4336
Coracto Rapamycin Eluting
Coronary Stent Delivery System
31-1117-MD/2012-Dc
MD-1117
11-7-2012
15-06-2015
ChronOS/ChronOS Inject (Bone
Void Filler) + 9
31-188-MD/2006-DC (ReReg. 02)
MD-188
11-7-2012
30-11-2015
33
166.
Sector-44, Gurgaon122002
M/s. St. Jude Medical
India Private Limited, D.
No. 8-3-168/B/1/18 & 19,
Laxmi Nagar, MCH, CircleV, Hyderabad
Oberdorf Switzerland
M/s. St. Jude Medical,
177 Country Road B,
East St. Paul MN 551117
having factory premises
at M/s. St. Jude Medical
Brasil Ltda, Rua
Professor Jose Vieira de
Mendonca, 1301 Bairro
Engenho Nogueira, Belo
Horizonte-MG-31.310260, Brazil
M/s. Alpha Bio techg
Limited, 7 Imber Street,
Kiryat Arye, POB 3936
Petach Tikva, Israel
49511
167.
M/s. Sark Healthcare
Private Limited, J-8, 1st
Floor, east Vinod Nagar,
Opp. Mayur Vihar-II, delhi110091
168.
M/s. Johnson & Johnson
Limited, j-1, Shree Arihant
Complex, Village Kalher,
Thane-Bhiwandi Road,
Distt-Thane, Bhiwandi
M/s. Mentor 3041 Skyway
Circle North Irving, texas
75038
169.
M/s. Smith & Nephew
Healthcare Private
Limited, Bldg 2-3 & 15-17
Rajlaxmi Complex, Opp
Hanuman Bus Stop
Kalher, Thane-421302
M/s. Smith & Nephew
Orthopaedic Limited, 1
Kingmaker Court,
Warwick Technology
Park, gallows hill,
Warwick CV 346 WG, UK
having factory premises
at M/s. Smith & Nephew
Orthopaedics Limited,
Biocor Valve Aortic and Mitral
Epic Valve Aortic and Mitral
Trifecta Valve Aortic
31-943-MD/2011-Dc
MD-943
16-7-2012
15-06-2015
Alpha Bio Tech dental Implant
System
Dental Implant-Titanium
Abutments-Titanium/SS
Healing caps, Cover Screw,
Screw and abutments, Bone
fixation Screws-Titanium
Saline Breast Implant with
Diaphragm Valve
(Smooth/Siltex/Siltex Contour
profile)
Spectrum Saline Breast Implant
(Smooth/Siltex/Siltex Contour
profile)
Breast Tissue Expanders
(Smooth/Siltex)
Birmingham Mid Head Resection
System
31-752-MD/2009-Dc
MD-752
16-7-2012
30-06-2015
31-1064-MD/2011-Dc
MD-1064
20-7-2012
30-06-2015
31-441-MD/2008-DC (ReReg. 10) End 01
MD-441
20-7-2012
30-03-2014
34
170.
M/s. St. Jude Medical
India Private Limited, D.
No. 8-3-168/B/1, Plot No.
18 and 19, laxminagar,
Behidn T.B. Hospital, MCH
Circle-V, mandal,
Hyderabad-500038
171.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
172.
M/s. 3M India Limited, No.
60/16, Huskar Road,
Electronic City, Bangalore560100
173.
M/s. Boston Scientific
India Private Limited, C41, Ground Floor, Okhla
Industrial Area, Phase-II,
New Delhi-110020
Aurora Spa Park,
Harrison Way,
Leamington Spa,
Warwick CV 31 3 HL, UK
M/s. Irvine Biomedical
Inc, 2375 Morse Avenue,
Irvine, CA 92614, USA
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537, USA
having factory premises
at M/s. Boston Scientific
Corporation, Tow Scimed
Place, Maple Grove, MN
55311-1566, USA
M/s. 3M Health Care, St.
Paul Minnesota 551441000, USA having factory
premises at M/s. Suzhou
ASvon Textile Co.
Limited, Yuanhe Town,
Xiangcheng Region,
Suzhou, City, Jiangsu
Province, China-215233
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537, USA
having factory premises
at M/s. Boston Scientific
Corporation, 302
Inquiry Diagnostic Catheters
Therapy Ablation Catheters
Inquiry Cardioversion Catheters
Saffire Blu Duo Ablation
Catheters
Therapy Cool Path Ablation
Catheters
Therapy Cool Flex Ablation
Catheters
Rubicon 14 Support Catheter
Sterling SL Monorail Balloon
catheter
Sterling SL Over-the-Wire
Balloon Catheter
31-23-MD/2006-DC (ReReg. 02)
MD-23
23-7-2012
30-06-2015
31-857-MD/2010-DC (End
03)
MD-857
23-7-2012
31-07-2014
3M Tegaderm Ag Mesh
Dressing with Silver (Contains
Silver Sulphate 8mg/g of
dressings)
31-1007-MD/2011-DC
MD-1007
23-7-2012
30-06-2015
Amplatz SuperStiff Guidewires
ChoICE Guide Wires
ChoICE PT Guide Wires
Luge PTCA Guidewires
Mailman PTCA Guide Wires
PT Graphix Guide Wires
PT1 Guide Wires
31-1080-MD/2012-DC
MD-1080
23-7-2012
30-06-2015
35
174.
175.
176.
M/s. Faith Biotech Private
Limited, E 107 Lajpat
Nagar-1, New delhi110024
M/s. Hester Diagnostics
Private Limited, Room No.
9, 1st Floor, 66, Princess
Street, Mumbai-400002
M/s. Uniapex Biomedics, 9
Krishna Kunj, Maharashtra
Nagar, Chandavarkar
Road, Borivali (W),
Mumbai-400092
177.
M/s. Johnson & Johnson
Limited, A1/50, Room No.
2, 100 Shed Area, GIDC
Vapi, Tal. Pardi (Valsad)
Gujarat
178.
M/s. Johnson & Johnson
Limited, A1/50, Room No.
2, 100 Shed Area, GIDC
Vapi, Tal. Pardi (Valsad)
Gujarat
Parkway, Global Park, La
Aurora, Heredia, Costa
Rica
M/s. Micro Vention Inc,
1311 Valencia Avenue,
Tustin, CA, USA 92780
V-18 Control Wires Guide sires
Transend Steerable Guide Wires
Scepter C Occlusion Balloon
catheter
31-804(A)-MD/2010-DC
(End 02)
MD-804(A)
1-08-2012
14-03-2014
M/s. Penumbra Inc, 1351
Harbor Bay Parkway,
Alameda, CA 94502,
USA
M/s. CPD S.p.A., Strada
per Crescentino, 13040
Saluggia (VC), Italy
Penumbra PX 400 Micro
catheter
31-499-MD/2008-DC (ReReg. 2011) End 01
MD-499
1-08-2012
30-09-2014
Chrono Carbostent (Cardiac
Stent)
Janus Optima Carbostent
(Tacrolimus Eluting Coronary
Stent)
Brio Pegaso SCRX (Balloon
Catheter)
Pro HP Pegaso (Balloon
catheter)
Charnley Stems (Standards)
C-Stems
Articul/Eze Femoral Heads
9/10 Cobalt Chrome (COCR)
Heads
31-1135-MD/2012-Dc
MD-1135
1-08-2012
15-07-2015
31-1149-MD/2012-Dc
MD-1149
1-08-2012
31-12-2015
SIG PS 150 Femoral
31-1065-MD/2011-Dc
MD-1065
1-08-2012
15-07-2015
M/s. DePuy International
Limited, St. Anthony’s
Road, Leeds, LS118DT,
England having factory
premises at M/s. Johnson
& Johnson Medical
(Suzhou) Limited No. 299
Chang Yang Street,
Suzhou Industrial Park,
Suzhou 215126, China
M/s. DePuy (Ireland)
Loughbeg, Ringaskiddy
Co. Cork Ireland having
factory premises at M/s.
DePuy Orthopaedics, 325
Paramount Drive,
Raynham Massachusetts
02767, USA
36
179.
M/s. Johnson & Johnson
Limited, A1/50, Room No.
2, 100 Shed Area, GIDC
Vapi, Tal. Pardi (Valsad)
Gujarat
180.
M/s. Karl Storz Endoscopy
India Private Limited, D181, Okhla Industrial Area,
Phase-I, New Delhi110020
M/s. Zimmer India Private
Limited, Plot No. B & B1
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill Kalher,
Thane-Bhiwandi Road,
Distt-Thane
181.
182.
183.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill Kalher,
Thane-Bhiwandi Road,
Distt-Thane
M/s. DePuy Orthopaedics
Inc, 700 Orthoapedic
Drive, Warsaw, Indiana
46581-0988 having
factory premises a tM/s.
CeramTec GmbH,
Medical Products Division
CeramTec-Platz, 1-9
73207 Plochingen,
germany
M/s. Karl Storz GmbH &
Co. KG Mittelstr, 8 78532
Tuttlingen, germany
Biolox Delta Ceramic Femoral
Head
Biolox Delta Ceramax Ceramic
Inserts
31-1085-MD/2012-Dc
MD-1085
1-08-2012
15-07-2015
Mega Fix (C, CP, B, P)
(Bioabsorbable Interference
Screws)
31-645-MD/2009-DC
MD-645
1-08-2012
15-07-2015
M/s. Zimmer Inc, 1800
West Center Street,
Warsaw Indiana 46580,
USA
NCB Periprosthetic Plate
System
Motion Loc Screw for NCB
Polyaxial Locking Plate System
31-170-MD/2006-DC (rereg. 2009) End 05
MD-170
1-08-2012
31-07-2012
M/s. Crodis Corporation,
14201 North West, 60th
Avuenue, Miami Lakes,
Florida, 33014, USA
having factory premises
at M/s. Cordis de Mexico
SA de CV Circuito Intrior
Norte #1820 parque
Industrial Salvarcar,
Ciudad Juarez,
Chiuhuahua, CP 32575,
Mexico
M/s. Crodis Corporation,
14201 North West, 60th
Avuenue, Miami Lakes,
Florida, 33014, USA
having factory premises
Diagnostic Catheter
Guiding Catheters
Sheath Introducer Systems
Stent Systems
Vascular Closure devices
31-115-MD/2006-DC (ReReg. 02)
MD-115
1-08-2012
14-01-2016
Stabilizer Support, stabilizer
plus, stabilizer XS, stabilizer
markerwire & stabilizer balance
performance steerable
guidewires
31-1050-MD/2012-Dc
MD-1050
1-08-2012
15-07-2015
37
at M/s. lake Region
Medical, 340 Lake
Hazeltine Drive, Chaska
MN-55318, USA
184.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill Kalher,
Thane-Bhiwandi Road,
Distt-Thane
185.
M/s. Kirloskar
Technologies Private
Limited, D-97-98, Ground
Floor, Lajpat Nagar-1 New
Delhi-110024
186.
M/s. Prime Medica
Promotion Private Limited,
107, Neelkanth Estate, No.
1, Sativali Road, Vasai
(E)-401208, Dist-Thane
M/s. Surgimed, D-22
Okhla Industrial Area,
Phase-I, New Delhi110020
M/s. Allergan Healthcare
India private Limited, Shri
Arihant Comp. Bldg, No.
H-1 Gala No. 10, ThaneBhiwandi Road, DisttThane, Bhiwandi-421302
M/s. Pharma Leaf India
Private Limited, 2nd Floor,
Daarul Awkaf No, 06,
187.
188.
189.
M/s. Crodis Corporation,
14201 North West, 60th
Avuenue, Miami Lakes,
Florida, 33014, USA
having factory premises
at M/s. lake Region
Medical Limited,
Butlersland New Ross,
Co. Wexford Ireland
M/s. Qualimed Innovative
Medizinprodukte GmbH,
Boschstrabe 16, D-21423
Winsen, Germany
M/s. Prime Medical Inc,
189, 189-4 Gumdang-ri,
Mado-myon Hwasungshi, Kyunggi-do, Republic
of Korea
M/s. Vascular Solutions
Inc, 6464 Sycamore
Court, Minneapolis,
Minnesota 55369, USA
M/s. Allergan, Route de
Promery, Zone Artisanale
de pre Mairy 74370
Pringy, France
M/s. Enzy-Surge Limited,
26, Shabazi Street Rosh
Ha Ayin-48021 Israel
Wizdom & Wizdom ST Steerable
Guidwiers
Jindo Tapererd Peripheral
Guidewires
SV .018 Peripheral Guidewires
ATW ALL Track Wire & ATW
Marker Wires,
Emerald Diagnostic Guidewires
Shinobi & Shinobi Plus
Steerable Guidewire
31-1049-MD/2012-DC
MD-1049
1-08-2012
15-07-2015
Juturna-c PTCA Balloon catheter
Suna-Stent Delivery System
Emax-Aspiration Catheter
Una-Stent Delivery System
Navalis Peripheral Vascular Self
expanding Stent System
Splints (Limb/Body/Ear)/Collar
31-1097-MD/2012-Dc
MD-1097
2-08-2012
15-07-2015
31-1101-MD/2012-Dc
MD-1101
2-08-2012
15-07-2015
GuideLiner V2 Catheter
31-202-MD/2006-DC (ReReg. 2010) End
MD-202
2-08-2012
14-09-2013
Hyaluronic Acid with Lidocaine
31-483-MD/2008-DC (Rereg. 01) End 01
MD-483
2-08-2012
31-05-2015
SilverStream
31-1133-MD/2012-Dc
MD-1133
2-08-2012
15-07-2015
38
Cunningham Road,
Bangalore-560052
190.
191.
192.
193.
M/s. Montrea Medicals Inc,
301, 3rd Floor, Ravinder
Plaza, 16/10178, Abdul
Aziz Road, Karol bagh,
New Delhi-110005
M/s. Emergent Medi-Tech
India Private Limited, 118,
Damji Shamji Industrial
Complex, 9 LBS Marg,
Kurla (W), Mumbai400070
M/s. Johnson & Johnson
Limited, A1/50, Room No.
2, 100 Shed Area, GIDC
Vapi, Tal. Pardi (Valsad)
Gujarat
M/s. Kimberly-Clark
Hygiene Products Private
Limited, Survey No. 279,
raisoni Industrial park,
Village-Mann, talukaMulshi Pune-411057
having factory premises
at M/s. Anteco Pharma
LLC, 925 development
Drive, PO Box 100, Lodi,
WI 53555, USA
M/s. Ortho Select GmbH,
Eltastrasse 2, D-78573,
Wurmilgen, Germany
M/s. Volcano
Corporation, 2870 Kilgore
Road, Rancho Crodova,
CA 95670, USA
M/s. Codman and
Shurtleff Inc, 325
Paramount Drive,
Raynham,
Massachusetts, USA
having factory premises
at M/s. Medos SARL,
Rue Girardet 29, CH2400 Le Locle,
Switzerland
M/s. Kimberley-Clark
1400 Holcomb Bridge
Road, Reswell, GA
30076, USA having
factory premises at M/s.
Unomedical SDN BHD,
Bakar Arang Industrial
Estate, Sungai Petani,
Malaysia 08000
Orthopaedic Implants:
Plates
Screws
Interlocking Nails
Locking Screw (locking nails)
Eagle Eye Gold Intravascular
Ultrasound Imaging catheter + 8
31-1009-MD/2011-DC
MD-1009
2-08-2012
15-07-2015
31-363-MD/2012-DC (ReReg. 02)
MD-363
6-08-2012
15-07-2015
Codman Holter Products
Accu-Flo Catheters
Codman Hakim Precision, Micro
Precision, Programmable and
Micro Programmable Valve
System
Codman Atrial Shunt
External Drainage Systems
Bactoseal EVD (External
ventricular Drainage)
Microsensor basic Kit,
Microsensor Bolk Kit,
Microsensor Skull Bolt Kit
Kimberly-Clark KimVent
Microcuff Endotracheal Tube for
Adults
Kimberly-Clark KimVent
Microcuff Endotracheal Tube for
Pediatrics, Oral/Nasal Magill
Kimberly-=Clark KimVent
Microcuff Endotracheal Tube for
Pediatrics, oral Curved
31-122-MD/2006-DC (Rereg. 02)
MD-122
6-08-2012
14-02-2016
31-1071-MD/2012-DC
MD-1071
13-08-2012
31-07-2015
39
194.
195.
M/s. Mur & Mur
Biosciences and Health
Limited, 758-A GF 1 to 9
Mount Chambers, Ground
Floor, Anna Salai,
Chennai-600002
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
Dist-Thane, Bhiwandi
196.
M/s. Coral Healthcare
Private Limited, 71 B.R.B.
Basu Road, 5th Floor,
Room No. A-524 Kolkata700001
197.
M/s. Smith & Nephew
healthcare Private Limited,
Bldg No. 2-3 & 15-17
Rajlaxmi Complex, Opp.
Hanuman Bus Stop
Kalher, Thane Bhiwandi
Road, Dist-Thane-421302
M/s. BioCer
Entwicklungs-GmbH,
Ludwig-Thoma Strasse
36c, 95447 Bayreuth,
Germany
HaemoCer Haemostatic Powder
31-1081-MD/2012-Dc
MD-1081
13-08-2012
31-07-2015
M/s. Ethicon LLC, 475 C
Street Los Prailes
Industrial park,
Guaynabo, Puerto Rico
00969, USA having
manufacturing premises
at M/s. Johnson &
Johnson do Brasil
Industria e Comercio de
produtos para Saude
Ltds, Rodovia, Presidente
Dutra, KM 154, Sao Jose
dos Campos Sao Paulo,
Brasil CEP 12240-908
M/s. Okamoto Industries
Inc, 3-27-12 Hongo,
Bunkyo-ku, Tokyo, Japan
having factory premises
at M/s. Okamoto
Industries Inc, Ibaraki
Platn, 1 Nishiyama,
Itabashi-Cho Ryugasaki,
Ibaraki-Pref, Japan
M/s. Smith & Nephew Inc,
Endoscopy division, 150
Minuteman Rd, Andover,
MA 01810, USA having
factory premises at M/s.
Smith & Nephew Inc, 130
Forbes Boulevard,
Mansfield,
massachustees, USA
Vicryl Rapide-Polyglactin 910
Synthetic Absorbable sutures
31-1092-MD/2012-Dc
MD-1092
13-08-2012
31-07-2015
Latex Prophylactics-Condoms
(Finished)
31-520-MD/2008-DC
MD-520
13-08-2012
15-07-2015
Suture (Fast-Fix 360 Needle
Delivery System)
31-431-MD/2007-DC (reReg. 2011) End 02
MD-431
13-08-2012
31-12-2014
40
198.
199.
M/s. Meril Lifesciences
India Private Limited, 512513, MIDAS Sahar Plaza
Complex, Near Kohinoor
Continental Hotel, MV
Road, J B Nagar, Andheri
East, Mumbai-400059
M/s. Bioaide Technology
Private Limited, 207,
Savitri Cinema Complex,
Greater Kailash-II, New
delhi
200.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-188
(part), Chamunda Comp.
Kasheli Village, Dist
Thane, Bhiwandi 421301
201.
M/s. Indian Surgical
Systems, B-2/2, 2nd Floor,
Double Storey, ramehs
Nagar, New Delhi-110015
202.
M/s. Lensai Opthalmic
Private Limited, A6-101.
La Habitat, Off 100 Feet
Road, Ahmedabad Tal;
Ahmedabad-II-380059
M/s. Maxx Othopedics
Inc, 531 Plymouth Road
(Plymouth Woods) Suite
526, Plymouth Meeting,
PA 19462, USA
Maxx Orthopaedic Freedom
Total Knee System
31-635-MD/2009-Dc
MD-635
13-08-2012
15-07-2015
M/s. Clotplus Limited,
regus House, Block 4,
Harcourt Road, Dublin 2,
Ireland having factory
premises at M/s. Starch
Medical Inc, No. 9th South
JinGuang Street,
Liangxiang Industrial
Zone, Beijing China
M/s. Medtronic Inc, 710
Medtronic parkway NE
Minneapolis MN-55432,
USA having factory
premises at M/s.
Medtronic Vascular, 3537 A Cherry Hill Drive,
Danvers, MA 01923
Seal Foam Absrobable
Polysaccharide Hemostat
Responder Polysaccharide
Hemostat
31-1018-0MD/2011-DC
MD-1018
13-08-2012
15-07-2015
Launcher Guiding Catheter
Catheter Guidewire
Export Catheters and Export XT
Catheters
Guard Wire Temporarry
Occlusion and Aspiration
System
Sherpa NX Guiding Catheters
Pulmonary Wedge Pressure
catheters
Brockenbrough Needles
Export AP Catheters
Orthopaedic Implants
LOSPA IS Spinal System
31-63-MDS/2006-DC (ReReg. 02)
MD-63
13-08-2012
31-08-2015
31-1019-MD/2011-Dc
MD-1019
13-08-2012
31-07-2015
1.PMMA Intraocular Lens
Hydrophilic Acrylic Intraocular
Lens
2.Hydrophobic Acrylic
Intraocular Lens
31-52-MD/2006-DC (rereg. 02)
MD-52
24-08-2012
31-07-2015
M/s. Crentec Co. limited,
247 Giro-ri, Ipjang-myeon
Seobuk-gu, Cheonan-si,
Chungcheongnam-do,
331-822, Korea
M/s. USIOL Inc 2500
Sandersville Road,
Lexington Kentucky40511, USA
41
203.
M/s. Kimberly Clark
Hygiene Products Private
Limited, Survey-No. 279
Raison Industrial Park,
Viollage Mann, TalukaMulshi Pune-411057
204.
M/s. Alcon Laboratories
India Private Limited, No.
03, 5th Floor, RMZ Infinity
Tower D, Unit No. 502,
Old Madras Road,
Benniganahalli,
Bangalore-560016
M/s. Zimmer India Private
Limited, Plot B & B1
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar-Phase-V, Gurgaon122016
M/s. Lensai Ophthalmic
Private Limited, A6-101 La
Habitat, Off 100 Ft Road,
Thaltej, Ahmedabad380059
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed188(Part), Chamunda
Comp., Kasheli Village,
Dist, Thane, Bhiwandi421301
205.
206.
207.
M/s. Kimberly-Clark 1400
Holcomb Bridge Road,
Roswell GA 30076 USA
having factory premises
at M/s. Avent S. de R.L.
de C.V. Carretera
Internacional Salida Norte
1053, Magdalena,
Sonora, Mexico CP
84160
M/s. Alcon Research
Limited, 6065 Kyle Lane,
Huntington, West Virginia
25702, USA
M/s. Zimmer Dental Inc,
1900 Aston Avenue,
Carlsbad, CA 92008,
USA
M/s. USIOL Inc, 2500
Sandersville Road,
Lexington, Kentucky40511, USA
M/s. Medtronic Sofamor
Danek, USA Inc, 1800
Pyramid Place, Memphis
TN 38132 having factory
premises at
M/s. Medtronic Puerto
Rico Operations Co.
Road 909, km 0.4 Barrio
Mariana Humacao, PR
00792, USA
Kimberly-Clark Kim vent Closed
sunction system for adults
double swivel Elbow
configurations + 6
31-1045-MD/2011-DC
MD-1045
24-08-2012
31-07-2015
PMMA Intraocular Lenses
AcrySof Single Piece Intraocular
Lenses
AcrySof Multi-Piece Intraocular
Lenses
AcrySof Restror Intraocular
Lenses
Tapered Screw Vent Dental
Implant
Screw-Vent dental Implant
Implant MTX surface Swiss Plus
31-16-MD/2006-DC (ReReg. 02)
MD-16
24-08-2012
31-07-2015
31-254-MD/2007-DC (Rereg. 02)
MD-254
24-08-2012
29-02-2016
1. PMMA Intraocular Lens
2.
Hydrophilic Acrylic Intra Ocular
Lens
3.
Hydrophobic Acrylic Intra Ocular
Lens
1. Atlantis® Anterior Cervical
Plate System
2. CD Horizon® Spinal System
3. Vertex® Reconstruction
System
4. Zephir® Anterior Cervical
System
31-52-MD/2006-DC (ReReg.02 )
MD-52
24-08-2012
31-07-2015
31-584-MD/2009-DC (ReReg.01)
MD-584
3-9-2012
14-01-2016
42
208.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-188
(Part), Chamunda Comp.
Kasheli Village, DistThane, Bhiwandi-421301
M/s. Medtronic Inc, 710
Medtronic Parkway N.E.
Minneapolis, MN 55432,
USA
having factory premises
at
M/s. C.R. Bard Inc, 289
Bay Road, Queensbury,
NY 12804, USA
Archer Super Stiff Guidewire
31-341-MD/2007-DC (ReReg 2010) (End 02)
MD-341
3-9-2012
14-08-2013
209.
M/s. Johson & Johnson
Ltd.,
A-1/50, Room No. 2, 100
Shed Area, G.I.D.C., Vapi,
Taluka Pardi, Distt.
Valsad, Gujarat
M/s. DePuy (Ireland)
Loughbeg, Ringaskiddy
Co. Cork, Ireland
Having factory premises
at
M/s. DePuy Orthopaedics
Inc, PO Box 988, 700
Orthopaedics Drive,
Warsaw, Indiana, 46581,
USA
DePuy Gription ™ Acetabular
Augment System
Augment
Buttress
Hip System
31-1029-MD/2011-DC
MD-1029
5-9-2012
15-08-2015
210.
M/s. Novaxa Enterprises
Private Limited, Shop No.
19, Commercial Shopping
Complex, Packet E-Mayur
Vihar, Phase-II, New
Delhi-110091
M/s. Leader Italia srl, Via
Aquileja, 49-20092
Cinisello Balsamo (MI),
Italy
Dental Implant
Implus Family
Tixos Family
31-985-MD/2011-DC
MD-985
11-9-2012
31-08-2015
211.
M/s. Carl Zeiss India
(Bangalore) Private
Limited, 22, Kensington
Road, Ulsoor, bangalore560008
M/s. Carl Zeiss meditec
AG, Goeschwitzerstrasse
51-52, 07745 Jena,
Germany
Having factory premises
at M/s. Carl Zesis
Meditec SAS, Avenue
Paul Langevin B.P. 5,
Intraocular Lens
31-1028-MD/2011-DC
MD-1028
11-9-2012
31-08-2015
43
212.
M/s. Lensai Ophthalmic
Private Limited, A6-101 La
Habitat, Off 100 Feet
Road, Thaltej,
Ahmedabad-380059
17053 LZ Rochelle
Cedex 9, France
M/s. Ophtec BV,
Schweitzerlaan 15, 9728
NR Groningen, P.O. Box
398, 9700 AJ Groningen,
The Netherlands
213.
M/s. Indo-Swiss Surgical
Co., B-46 (LG-4), Main
Road, Kalkaji, New Delhi110019
M/s. AL. CHI. MLA, S.r.L.,
Viale Austria 14 35020
Ponte S. Nicolo (PD),
Italy
1. Silicone Oil (Polydimethyl
Siloxane)
2. Intraocular Gases
(Octafluropropane)
31-1100-MD/2012-DC
MD-1100
11-9-2012
15-08-2015
214.
M/s. Smith & Nephew
Healthcare Private
Limited, Bldg 2-3 & 15-17,
Rajlaxmi Complex, Opp.
Hanuman Bus Stop,
Kalher, Thane-Bhiwandi
Road, Thane-421302
M/s. Smith & Nephew Inc,
ATEK Medical, LLC, 620
Watson SW, Grand
Rapids, MI 49504, USA
Having factory premises
at
M/s. Smith & Nephew Inc,
Advanced Wound
Management Division,
970 Lake carillon Drive,
St. Petersburg, FL 33716,
USA
RENASYS-F Foam Dressing Kit
with soft Port
31-1131-MD/2012-DC
MD-1131
11-9-2012
31-08-2015
215.
M/s. Vygon India Private
Limited, B-17, Sector-34,
Infocity, Gurgaon
M/s. Vygon SA, 5 Rue
Adeline 95440 Ecouen,
France
Centracath/Vygoflex + 27
Products
31-197-MD/2006-DC (ReReg. 02)
MD-197
11-9-2012
30-11-2015
216.
M/s. Johnson & Johnson
Ltd., J-1, Shree Arihant
Complex, Vill Kalher,
Thane-Bhiwandi Road,
Dist. Thane, Bhiwandi
M/s. Codman & Shurtleff
Inc, 325 Paramount
Drive, Raynham,
Massachusetts, 02767,
USA
Having factory premises
at
M/s. Codman & Shurtleff
Sterile Catheter
1. Prowler-P10, P-14 Infusion
Catheter
2. Prowler-Plus Infusion
Catheter
3. Prowler Select LP Infusion
Catheter
4. Prowler Select Plus Infusion
31-672-MD/2009-DC (Re
Re.01)
MD-672
11-9-2012
31-082015S
1. PMMA Intraocular LensArtisan
2Silicon
Intraocular Lens-Artiflex
31-1062-MD/2011-DC
MD-1062
11-9-2012
15-08-2015
44
Inc, Calle Circuito Interior
Norte, # 1820, Parque
Industrial Salvarcar,
Ciudad Juarez,
Chihuahua, CP 32575,
Mexico
Catheter
5. Envoy Guiding Catheter
217.
M/s. Johnson & Johnson
ltd., A-1/50, Room No.100
Shed Area, G.I.D.C., Vapi
Tal. Pardi (Valsad
M/s. DePuy (Ireland)
Loughbeg, Ringaskiddy
Co. Cork, Ireland
having f factory premises
at
M/s. Hunt Development
(UK) Limited, Packing
Units 15-18, Holmbush
Industrial Estate,
Midhurst, West Sussex,
UK, GU29 9HX
DeltaMotion® Acetabular Cups
(Sterile)
31-1046-MD/2011-DC
MD-1046
11-9-2012
15-08-2015
218.
M/s. Advance
Therapeutics Private
Limited, Plot # 1, 2nd
Floor, LSC, New Rajinder
Nagar, New Delhi-110060
M/s. Translumina GmbH,
Neue Rottenburger
Strasse 50, D-72379,
Hechingen, Germany
1. Yukon Choice DES +Coronary
Stent System
2. Yukon Choice 4 DES
Coronary Stent System (Sterile
& Non- Sterile)
3. Yukon Chrome DES Coronary
Stent System (Sterile & NonSterile)
31-74-MD/2006-DC (ReReg. 02)
MD-74
11-9-2012
15-08-2015
219.
M/s. Cure Surgicals, S-12,
1st Floor, Green Park
Extension, opp. Uphaar
Cinema, New Delhi110016
M/s. Paradigm Spine
GmbH, Eisenbahnstrasse
84, 78573 Wurmlingen,
Germany
1. Coflex-F Implant Ssytem
2. DSS dynamic stabilization
system
31-724-MD/2009--DC
(End. 01)
MD-724
11-9-2012
14-07-2013
220.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-188
(Part), Chamunda Comp.,
M/s. Medtronic Inc, 710
Medtronic Parkway
Minneapolis, MN-55432,
USA
1. Endeavor-Sprint-ZotarolimusEluting RX Coronary Stent
System + 25
31-64-MD/2006-DC (ReReg. 02)
MD-64
11-9-2012
15-08-2015
45
Kasheli Village, DistThane, Bhiwandi421301
Having factory premises
at
M/s. Medtronic Ireland
Parkmore Business Park,
West Galway, Ireland
221.
M/s. Abbott Healthcare
Pvt. Ltd., 4 Corporate
Park, Sion Trombay Road,
Chembur, Mumabi400071
HI-TORQUE POWERTURN
Guide Wire Family (Power turn
Ultra flex Guide Wire, Power turn
Flex Guide Wire, Power turn
Guide Wire
31-307-MD/2007-DC
(End.)
MD-307
11-9-2012
30-06-2013
222.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed188(Part), Chamunda
Comp., Kasheli Village,
Dist, Thane, Bhiwandi421301
M/s. Abbott Vascular,
3200 Lakeside Drive,
Santa Clara California
95054, USA having
factory remises at M/s.
Abbott Vascular, 26531
Ynez Road, Temecula,
California 92591, USA
M/s. Medtronic Inc 710
Medtronic Parkway N.E.
Minneapolis MN 55432,
USA
Having factory premises
at
M/s. Medtronic
Neurosurgery 125
Cremona Drive Goleta
CA93117, USA
1. Ventricular Catheters
2. Cardiac/Peritoneal catheter
3. Opus® ventricular Catheter
31-54-MD/2006-DC (Rereg. 02)
MD-54
4-10-2012
31-12-2015
223.
M/s. Fresenius Medical
Care India Pvt. Ltd., S-21,
2nd Floor, Star City MALL,
Mayur Vihar, New Delhi110092
M/s. Fresenius Medical
Care Ag & Co. KGaA, D61346 Bad Homburg,
Germany
Having factory premises
at
M/s. Fresenius Medical
Care -SMAD, Z.I.de la
Pontchonniere, Route de
la Chanade, Savigny F69591 L'Abresla Cedex,
France
1Sodium Bicarbonate (bibag)
2.Granudial
31-1086-MD/2012-DC
MD-1086
4-10-2012
31-08-2015
46
224.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick,
MA 01760-1537, USA
Having factory premises
at
M/s. Boston Scientific
Ireland Limited, Ballybrit
Business Park, Galway,
Ireland
1. OffRoad™ Re-Entry Catheter
System
2. 2cm Peripheral Cutting
Balloon
3. Small Peripheral Cutting
Balloon
31-41A-MD/2006-DC (Re
Reg.2009) End 05)
MD-41 A
4-10-2012
31-03-2013
225.
M/s. Lifetech Scientific
India Private Limited, # 3,
1st main, 3rd Floor, BDA
Layout, Kodihally, HAL
2nd Stage, Bangalore560008
M/s. Lifetech Scientific
(Shenzhen) Co. Limited,
Floor 1-3, Cybio
Electronic Building,
langshan 2nd Street,
North Area of High-tech
park, nanshan District,
Shenzhen, 518057,
China
1. HeartR Patent Ductus
Arteriosus Occulder
2.HeartR Atrial Septal Defcet
Occuldre
3.HeartR Ventricular Septal
Defect Occulder
4. SteerEase Introducer
31-834-MD/2010-DC (End.
01)
MD-834
4-10-2012
14-03-2014
226.
M/s. Johnson & Johnson
ltd., A-1/50, Room No.100
Shed Area, G.I.D.C., Vapi
Tal. Pardi (Valsad)
M/s. DePuy France SAS,
7 Allee, Irene Joliot Curie,
BP 256, 69801, Saint
Priest cedex, France
Having factory premises
at
M/s. Johnson & Johnson
Medical (Suzhou)
Limited, No. 299 Chang
Yang Street, Suzhou
Industrial Park, Suzhou
Jiangsu 215126, China
Autobloquante Femoral
Cemented Stem (Orthopaedic
Implants)
31-1105-MD/2012-DC
MD-1105
4-10-2012
31-08-2015
227.
M/s. Abbott medical Optics
Private Limited, No. 91,
G.N.T. Road,
Madhavaram, Chennai600110
M/s. Abbott Medical
Optics Inc, 1700 E. St.
Andrew Place, Santa
Ana, California 92705,
USA
Dura Lens II Intraocular Lens
31-20-MD/2006-DC (Rereg. 02)
MD-20
4-10-2012
31-05-2016
47
Having factory premises
at
M/s. Aaren Scientific Inc,
4290 E, Brickell Street,
Ontario, California 91761,
USA
228.
M/s. Paradigm Medivision
Private Limited, "Laurel
House", Plot No. 535/304/1/1, Mythri Nagar,
Kukatpally-500072,
Hyderabad
M/s. Maco Pharma SA,
Rue Lorthiois-59420,
Mouvaux, France
Having factory premises
at M/s. Macoprodcutions
200 Chaussee Fernand
Forest-59200 Tourcoing
(France)
1. Single or Multiple Blood Bag
with anticoagulant solution
CPDAI (With or without in-line
filter)
2. Single or Multiple Blood Bags
with anticoagulant solution
CPD/SAGM (with or without inline filter)
31-1174-MD/2012-DC
MD-1174
4-10-2012
31-08-2015
229.
M/s. Covidien Healthcare
India Private Limited,
"Doshi Towers", 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Micro Therapeutics
Inc, d/b/a ev3
Neurovascular, 9775
Toledo Way, Irvine, CA
92618, USA
1. Axium™ Detachable Coil
System-PGLA
2. Axium™ Detachable Coil
System-Nylon
3.SilverSpeed
4.X-Celerator
X-Pedion
Mirage
31-51A-MD/2006-DC (ReReg. 2011) End 02
MD-51 A
4-10-2012
14-05-2014
230.
M/s. Paul Hartmann
Medical private Limited,
Requs Suburb Centre
Private Limited, level-4,
Dynasty Business Park, A
Wing, Andheri Kurla Road,
Andheri East, Mumbai400059
M/s. Paul Hartmann AG,
Paul Hartmann Str-12, D89522 Heidenheim,
Germany
Having factory premises
at
M/s. IVF Hartmann AG,
Victor-von-Bruns-strasse
28, 8212 Neuhausen,
Switzerland
Tenderwet
31-955-MD/2011-DC
MD-955
4-10-2012
31-08-2015
231.
M/s Euro Medi Tools Pvt.
Ltd. C-108, Ground Floor,
M/s Linvatec Corporation
d/b/a ConMed Linvatec,
1. Bioabsorbable Implants (for
Knee) 2. Metal Implants (for
31-891-MD/2010-DC
MD-891
4-10-2012
31-8-2015
48
Dayanand Colony, Lajpat
Nagar- IV, New Delhi 110024
11311 Concept Blvd.
Largo, FL 33773, USA
Knee)
3. Anchor for
Rotator Cuff & Instability
Systems- Bioabsorable
4. Anchor for Rotator Cuff &
Instability Systems - Metal
5. Anchor for Rotator Cuff &
Instability Systems - Peek
232.
M/s. Zimmer India Private
Limited, Plot No. B & B1,
Vanijya Nikunj, 7th Floor,
Enkay Tower, Udyog
Vihar, Phase-V, Gurgaon122016
NexGen® Complete Knee
Solution (Femoral Components)
31-1119-MD/2012-DC
MD-1119
17-10-2012
15-09-2015
233.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
District-Thane, Bhiwandi
M/s. Zimmer Inc, 1800
West Center Street,
Warsaw IN 46580, USA
Having factory premises
at M/s. Zimmer
Orthopaedics
Manufacturing Ltd.,
Building # 2, East Park,
Shannon Industrial
Estate, Co., Clare ,
Ireland
M/s. Ethicon Inc, Route
22 West, Somerville, New
Jersy 08876-0151, USA
Having factory premises
at
M/s. Ethicon Inc, Calle
Durango No. 3751 Lote
Bravo, Ciudad Juarez,
Chihuahua 32575,
Mexico
PDS* Plus (Polydioxanone)
Antibacterial Suture
PDS* II Suture
3.MONOCRYL* Plus
Antibacterial (Poliglrcaprone 25)
Synthetic Absorable Suture
MONOCRYL* (Poligecaprone
25) Synthetic Absorable Suture
VICRYL PLUS* Antibacterial
(Polyglactin 910) Suture
VICRYL* (Polygactin 910)
Suture
ETHILON* Nylon Ployester
Surgical Stainless Steel Suture
Mersilene* Polyester Fiber
Suture
Nuolon* Nylon Suture
Surgical Gut Suture-Plain &
Chromic
31-1144-MD/2012-DC
MD-1144
17-10-2012
15-09-2015
49
234.
M/s. Synthes Medical
Private Limited, 118-P,
Sector-44, Gurgaon
M/s. Synthes GmbH,
Eimattstrasse 3, CH-4436
Oberdorf, Switzerland
Vertecem V+ System
31-188-MD/2006-DC (Re
Reg. 2009) End. 02
MD-188
17-10-2012
31-11-2012
235.
M/s. Nipro Corporation
Pvt. Ltd.,
New No. 167, Old No. 137,
Yesdee House, 1st Floor,
Valluvarkottam High Road,
Nungambakkam, Chennai600034
M/s. Nipro Corpoartion 39-3 Honjo Nishi, Kita Ku ,
Osaka, Japan having
factory premises at
M/s. Nipro Medical
Industries Limited, 2-1964, Matsubara,
Tatebayashi-Shi, Gunma,
374-8518, Japan
1.Guide Wire
2.Nipro Spinal Needles
3. Dental Needles
31-1078-MD/2012-DC
MD-1078
17-10-2012
15-09-2015
236.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai - 400036
M/s. Biosense Webster
Inc, 3333 Diamond
Canyon Road, Diamond
Bar, California 91765,
USA
Having factory premises
at
M/s. Biosense Webster
Inc, 15715 Arrow
Highway, Irwindale,
California 91706, USA
Thermocool SMARTTOUCH
Catheter
31-120-MD/2006-DC (ReReg. 09) End. 02
MD-120
17-10-2012
14-02-2013
237.
M/s. Becton Dickinson
India Private Limited, No.
34, Assisi Nagar, West
Thottam, Madhavram,
Chennai-51
M/s. Becton Dickinson
and Co., 1 Becton Drive
Franklin Lakes, NJ
07417, USA
Having factory premises
at
M/s. Becton Dickinson
and Company (BD), 1575
Airport Road, Sumter, SC
29153, USA
1.Blood Collection Needles
2. BD Vacutainer Multisample
Luer ADAPTOR
3. Push Button Blood Collection
Sets
4. Safety Lok Blood Collection
Set
5.BD Acutainer Passive
Shielding Blood Collection
Needles
31-658-MD/2009-DC (Re
Reg.02)
MD-658
17-10-2012
31-03-2016
238
M/s Vishal Sugical
M/s Gebruder Martin
1.Non-Sterile Plates, Screws,
31-913-MD/2011-DC
MD-913
17-10-2012
15-09-2015
50
Equipment Co. Pvt. Ltd.,
Melaram Complex, No. 23,
Wallers Road, Chennai600002
GmbH & Co. KG,
Ludwigstaler Strasse 132,
D-78532 Tuttlingen,
Postfach 60, D-78501,
Tuttlingen, Germany
Having factory premises
at
M/s Stuckenbrock
Medizintechik GmbH,
Lessing Str. 50, 78532
Tuttlingen, Germany
Nails of various sizes-Titanium
2.Non Sterile Plates, Screws,
Nails of various sizes-Stainless
Steel
239.
M/s. Micro Medical, 503,
Vishal Bhawan, 95, Nehru
Place, new Delhi-110019
M/s. Toray Industries Inc,
1-1, NihonbashiMuromachi, 2-chome,
Chuo-ku, Tokyo 1038666, Japan
Having factory premises
at
M/s. Toray Industries Inc,
Seta Plant 1-1, Oe 1Chome, Otsu, Shiga 5202141, Japan
Inoue-Balloon Catheter
31-1130-MD/2012-DC
MD-1130
17-10-2012
30-09-2015
240.
M/s. Epsilon Eye Care Pvt.
Ltd., Ground Floor 49,
Plihil-3, Tithal Road,
Valsad
M/s. Aaren Scientific Inc,
International Inc 4290
East Brickell Street,
Building A, Ontario CA
91761, USA
Intraocular Lens
1. Biovue
Family
2. PMMA Family
3. Heparin PMMA Family
4. Aqua (Hydrophilic) Family
5. EC (Hypodermic) Family
6. Optivis
31-14-MD/2006-DC (ReReg. 01)
MD-14
17-10-2012
15-09-2015
241.
M/s. DePuy Medical Pvt.
Ltd., Plot No. 04, Survey
No. 277/4, Demni Road,
Village-Dadar & Dadar
Nagar Haveli (UT)
M/s. DePuy International
Limited trading as M/s.
DePuy CMW, Cornford
Road, Blackpool, FY4
4QQ, England, UK
Bone Cement
31-915-MD/2011-DC
(End.01)
MD-915
23-10-2012
31-05-2014
242.
M/s. Johnson & Johnson
M/s. DePuy Mitek, 325
1. Sterile Metalic Anchors
31-1141-MD/2012-DC
MD-1141
23-10-2012
31-10-2015
51
ltd., A-1/50, Room No.100
Shed Area, G.I.D.C., Vapi
Tal. Pardi (Valsad)
Paramount Drive,
Raynham, MA 02767,
USA
Having factory premises
at
M/s. DePuy Mitek SARL,
Rue du Puits Godet 20
Neuchatel, CH-2000,
Switzerland
2. Sterile Bio Anchors
(End 01)
243.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-188
(Part), Chamunda Comp.
Kasheli Village, DistThane, Bhiwandi-421301
M/s. Medtronic Inc, 710
Medtronic Parkway N.E.
Minneapolis, MN 55432,
USA
Having factory premises
at
M/s. Medtronic Ireland,
Parkmore Business Park,
West, Galway, Ireland
Catheter
31-64-MD/2006-DC (Rereg. 02) End. 01
MD-64
23-10-2012
15-08-2015
244.
M/s. India Medtronic
Private Limited, Plot No.
609, Survey/Shed-188
(part), Chamunda Comp,
Kasheli Village, DistThane, Bhiwandi-421301
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
premises at
M/s. Availmed SA, de
C.V. (Mexico) Ave. Paseo
Regorma No. 8950
Interior Edificio (B1, C1,
E1, E2, F2, G1 (local
A,B.C,G,H) La Mesa,
Tijuana, Baja California,
Mexico 22116
1. Cardiovascular Angiographic
Catheters
2. Everest and Accessories
3. Input Introducers
31-1070-MD/2011-DC
MD-1070
23-10-2012
30-09-2015
245.
M/s St Jude Medical India
Pvt. Ltd., D. No 8-3168/B/1, Plot No/ 18 & 19,
Laxmi Nagar, Behind T.B.
M/s. Brivant Limited,
Parkmore West Business
Park, Galway, Ireland
CPS Courier/ Guide wire
31-726-MD/2009-DC (Re
Reg.01)
MD-726
23-10-2012
31-01-2016
52
246.
Hospital, MCH Circle-5,
Mandal, Hyderabad Dist
M/s. Vascular Concepts
Limited, 7C,
Doddaballapur Industrial
Estate, Doddaballapur,
Bangalore-561203
M/s. Eucatech AG,
Gottlieb-Daimler-Str-2, D79618, Rheinefelden,
Germany
Prostar/ Balloon Expandable
Peripheral Stent (Non Sterile)/
aisi 316l
31-03-MD/2006-DC (Rereg. 2009) End 02
MD-03
23-10-2012
28-02-2015
247.
M/s. Cochlear Medical
Device Co. India Private
Limited, Unit No. G-3,
Ground Floor, Platina
Building, CTS Nos. 4207
C-59, G Block, Bandra
Kurla Complex, Bandra
(E), Mumbai-400051
M/s. Cochlear Limited, 14
Mars Road, Lane Cove
NSW 2066, Australia
Nucleus/ Cochlear implant with
straight electrode/ C1422
31-81-MD/2006-DC (ReReg. 2009) (End 01)
MD-81
23-10-2012
15-04-2015
248.
M/s. Alkem Laboratories
Ltd., Old No. D-10/6, 1st
Floor, TTC Industrial Area,
MIDC, Turbhe, Navi
Mumbai Dist. Thane400705, Maharashtra
M/s. Oculus Innovative
Sciences Inc., 1129 North
McDowell Blvd.
Petaluma, ca 94954, USA
having factory premises
at
M/s. Oculus Technologies
of Mexico SA de, C.V.
Industria Vidriera No. 81,
Col. Industrial Zapopan
Norte, C.P. 45130,
Zapopan Jalisco, Mexico
Plastic Bottle/
Super Oxidized Solution for
wound healing
31-1114-MD/2012-DC
MD-1114
29-10-2012
15-10-2015
249.
M/s. Stryker India Pvt.
Ltd., Khasra No. 191-193,
1st Floor, Asola Village,
Fatehpur Beri, New Delhi
M/s. Stryker Trauma
GmbH, Prof.-KuntscherStrabe 1-5, D-24232
Schonkirchen Germany
Gamma 3/ Nail Locking Ssytem
31-179-MD/2006-DC (Rereg. 2001)
MD-179
30-10-2012
30-09-2015
250.
M/s. Synthes Medical Pvt.
Ltd., Plot No. 118-P,
Sector-44, Gurgaon-
M/s. Synthes GmbH,
Eimattstrasse 3, CH-4436
Oberdorf, Switzerland
Vertabral Body Stentinf System/
Vertebral Body Stent (Small/
Medium/ Large)/ Vertebral Body
31-188-MD/2006-DC (ReReg. 2009) End.05
MD-188
1-11-2012
30-11-2012
53
122002 (Haryana)
251.
M/s. Abbott medical Optics
Private Limited, No. 91,
G.N.T. Road,
Madhavaram, Chennai600110
M/s. Abbott Medical
Optics Inc, 1700 E. St.
Andrew Place, Santa
Ana, California 92705,
USA
Having factory premises
at
M/s. Abbott Medical
Optics (AMO) Groningen
B.V. of Van Swiwtenlaan
5, 9728 NX Groningen,
The Netherlands
252.
M/s. Ranbaxy Laboratories
Ltd., Jai Matadi Comp,
Godown No. P-6, Ground
Floor, Thane-Bhiwandi
Road, Kalher, Dist Thane
Bhiwandi, Maharahstra
M/s. Sirtex Medical Ltd.,
Level 33, 101 Miller
Street, North Sydney,
NSW 2060 Austrailia
Having factory premises
at
M/s. Sirtex Singapore, 50
Science Park Road, #0101 The Kendall,
Singapore
253.
M/s. B. Braun Medical
(India) Pvt. Ltd., Building
No. B, Gala No. 1-10,
Prerna Complex, Anjur
Phata, Dapoda Road at
Val Village, Bhiwandi
421302 Maharahstra
M/s. B. Braun Melsungen
AG, Carl-Braun-Str., 1,
34212 Melsungen,
Germany
Having factory premises
at
M/s. B. Braun Aesculap
Japan Co. Limited,
Tochigi Factory-Hospital
Care, 285 Ogaki, TsugaMachi, Tochigi-Shi,
Tochihi, 328-0101, Japan
Stent W/ Ballon(Small/ Medium/
Large)/
Tecnis/ Toric Multifocal 1-Piece
Soft Acrylic Intraocular Lens/
ZMT150, ZMT 225, ZMT 300,
ZMT 400
31-17-MD/2006-DC (Rereg. 2009) End 03
MD-17
5-11-2012
31-05-2013
SIR-Spheres/ Yttrium 90
Microspheres
31-1197-MD/2012-DC
MD-1197
6-11-2012
31-10-2015
1. Pencan/ Needles for Spinal
Anaesthesia
2. Spinocan/ Needles for Spinal
Anaesthesia
31-1067-MD/2011-DC
MD-1067
7-11-2012
15-10-2015
54
254.
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
District-Thane, Bhiwandi
M/s. ClearStream
Technologies Limited,
Myone Upper,
Enniscorthy Co. Wexford,
Ireland
1. Sleek (RX)/ Percutaneous
Trans luminal Aangioplasty
Balloon Catheter
2. Sleek (OTW)/ Percutaneous
Trans luminal Aangioplasty
Balloon Catheter
31-239-MD/2006-DC (ReReg. 02)
MD-239
12-11-2012
31-12-2015
255
M/s. Johnson & Johnson
Limited, J-1, Shree Arihant
Complex, Vill. Kalher,
Thane-Bhiwandi Road,
District-Thane, Bhiwandi
M/s. Ethicon Inc, Route
22 West, Somerville, New
Jersy 08876-0151, USA
Having factory premises
at
M/s. Ethicon Inc, Ave, de
las Torres No. 7125 Suite
Ethicon Cd, Juarez,
Chihuahua Mexico 32575
Gynecare Thermachoice III
Uterine Balloon Therapy
System/ Thermal Balloon
Ablation Catheter System for
Uterine Balloon Therapy (UBT)
31-1106-MD/2012-DC
MD-1106
12-11-2012
15-10-2015
256.
M/s. Synval, C-151,
Ground Floor, Doubel
Storey, Ramesh Nagar,
new delhi-110005
M/s. Signus
Medizintechnik GmbH,
Industriestrabe 2, D63755 Alzenau, Germany
1.ATHLET, NUBIC/NUBIC XL,
RABEA/ Cervical Inter Vertebral
Spacers
2.CONKLUSION, MONOPOLY/
Internal Spinal Fixation-Rod
System
3.CONTACT, TOSCA/ TOSCA
II/ Internal Spinal Fixation-Plate
Systems
4.ROTAIO/ Cervical Disk
Prosthesis
31-1031-MD/2011-DC
MD-1031
12-11-2012
15-10-2015
257.
M/s. Skyquest Technology
Consulting Pvt. Ltd., 606,
6th Floor, Sahjanand,
Shopping Centre, Opp.
Raj Hindi High School,
Shahibaug, Ahmedabad,
Area, Shahibagh
(Ahemedabad)-380004
M/s. Sahajanand Medical
M/s. Exciton
Technologies Inc, Suite
4000, 10230 Jasper
Avenue, Edmonton,
Alberta, T5J 4P6, canada
Exsalt SD7 Wound/ Wound
Dressing
31-1140-MD/2012-DC
MD-1140
12-11-2012
15-10-2015
M/s. Arthesys, 20, Rue
Sirius CTO/ PTCA Catheter
31-274-MD/2007-DC (Re-
MD-274
19-11-2012
14-09-2013
258.
55
259.
260.
Technology Pvt. Ltd., 2nd
Floor, Block No. B, Plot
No. 53 to 567, Sahajanand
Estate, Vakhariya Vadi,
Dabholi Char Rasta, Ved
Road, Surat 395004,
Taluka: Surat City, District
Surat-Gujarat
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal:Pardi (Valsad),
Gujarat
Traversiere, 92230
Gennevilliers, France
2.Y-Connectors (Sterile & NonSterile)
Reg. 2010) (End 02)
M/s. DePuy Mitek, 325
Poaramount Drive,
Raynham, MA 02767,
USA
Having factory premises
at
M/s. T.A.G. Medical
Products Corporation,
Kibbutz Gaaton- 25130,
Isarel
Bristow/ Latarjet Shoulder
Instability System (Non-Sterile)
31-1116-MD/2012-DC
MD-1116
19-11-2012
15-10-2015
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal:Pardi (Valsad),
Gujarat
M/s. DePuy International
Limited, St. Anthony's
Ropad, Leeds, LS11
8DT, UK
Charnely Hip Replacement
System-Femoral Stems, Cups,
Bridge, Plates, Harding Cement
Restrictor
2.C-Stem Femoral Stems, End
Cap, Centralizers
3.Duraloc Acetabular Cup
System-Cups, Enduron Liners &
Reinforcement Ring
4.Elite + Hip System-cups,
Stems, Heads
5.
Hasting Hip System-Heads,
Femoral Stems
6.Proxima Hip System
7.Silent Hip-Total Hip
Replacement System
8.Mobility Total Ankle System
9.LCS Complete Knee System
10.Ultamet & Articul/ eze System
31-132-MD/2006-DC (ReReg. 02)
MD-132
19-11-2012
31-10-2015
56
261.
M/s. Cofident Sales India
Pvt. Ltd., No. 47, 2nd
Floor, Pete Chennappa
Industrial Estate,
Kamakshipalya, Magadi
Main Road, Bangalore560079
M/s. MIS Implants
Technologies Ltd., ar Lev
Industrial Park, P.O.
Box7, Bar Lev, Israel
20156
262.
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal:Pardi (Valsad),
Gujarat
M/s Depuy Orthopeadic
Inc.,PO Box 988, 700
Orthopeadic Drive,
Warsay, Indiana 465810988, USA
Having factory premises
at
M/s Depuy (Ireland),
Loughbeg, Ringakiddy,
Co.Cork, Ireland
263.
M/s. Johnson & Johnson
Limited, A-1/50, Room No.
2, 100 Shed Area, GIDC,
vapi, Tal:Pardi (Valsad),
Gujarat
264.
M/s. Covidien Healthcare
India Private Limited,
"Doshi Towers", 6th Floor,
#156, Poonamallee High
11.S-Rom Hip System
1.Seven, Mistral, Lance,
Provisional, UNO one piece/
Dental Implant
2.BondBone/ Bone Grafting
Material (Synthetic-biphasic
calcium sulphate)
3.Orthodontic Anchor Screws
(Self-Tapping)
31-847-MD/2010-DC
MD-847
21-11-2012
15-11-2015
Hip Replacement Ssytem-Stem
& Sleeves/ S-ROM
2. Hip Replacement SystemLiners/ Duraloc
3.Knee Replacement SystemTibial Insert/ Sigma
4.Total Knee Replacement
System/ Sigma
5.Knee Replacement SystemMobile Bearing/ LCS
31-1160-MD/2012-DC
MD-1160
21-11-2012
31-10-2015
M/s. DePuy International
Limited, St. Anthony's
Road, Leeds, LS11 8DT,
UK
Having factory premises
at
M/s. Europlaz
Technologies Limited,
The Maltings Industrial
Estate, Southminster,
Essex, UK, CM0 7EH,
United Kingdom
Hip replacement System/ CStem Void Centralizers
31-660-MD/2009-DC (Re
Reg.01)
MD-660
23-11-2012
31-10-2015
M/s. Micro Therapeutics
Inc, d/b/a ev3
Neurovascular, 9775
Toledo Way, Irvine, CA
Embolization Device/ Pipeline
31-51A-MD/2006-DC (Re
Reg. 2011) End 04
MD-51 A
23-11-2012
14-05-2014
57
Road, Kilpauk, Chennai600010
92618, USA
265.
M/s. Max Neeman Medical
International Limited, Max
House, Ground Floor, 1,
Dr. Jha Marg, Okhla
Phase-III, New Delhi110020
M/s. Systagenix Wound
Management Limited,
("Systagenix") Gargrave,
North Yorkshire, BD23
3RX, United Kingdom
266.
M/s. B. Braun Medical
India Private Limited, Bldg
No. B, Gala No. 1-10,
Prerna Complex, Anjur
Phata Dapoda Road, At
Val Village Bhiwandi421302
M/s. B. Braun Melsungen
AG, Carl-Braun-Str. 1,
34212 Melsungen,
Germany
Having factory premises
at
M/s. Hakko Co. Limited,
1490 O-aza Isobe,
Chikuma Shi, Nagano,
389-0806, Japan
267.
M/s. Hexacath India,
Godown No, 42, Pune
Trade Centre, Gat No.
2337/1, Panchayat Haveli,
Zilla Parisahd Wagholi,
Tal. Haveli, Dist-Pune
M/s. Hexacath, 4,
Passage Saint-Antoine,
F-92508 Rueil-Malmaison
Cedexd, France
Having factory premises
at M/s. Hexacath 8
Avenue Charles de
Gaulles, F 25500
Morteau, France
1. Adaptic/ Non-Adhering
Dressing/
2012,2013,2014,2015,2018,201
9
2.Tielle/ Adhering Dressing
(Hydropolymer)/ MTL100,
MTL101. MTL102, MTL103,
MTL105
3.Tielle Sacrum/ Adhering
Dressing (Hydropolymer)/
MTL104
4. Tielle Xtra/ NonAdheringDressing
(Hydropolymer)/ MTO301,
MTP302, MTP305
Stimuplex A/ Needles and
Catheter Kits for Plexus
Anaesthesia/ 4894251,
4894260, 4894278, 4894367,
4894375, 4894502, 4894539
31-1122-MD/2012-DC
MD-1122
23-11-2012
31-10-2015
31-88-MD/2012-DC (Re
Reg.02)
MD-88
23-11-2012
14-01-2016
Premounted Coronary Stent
System/ Helistant Titan 2
31-59-MD/2006-DC (ReReg. 02)
MD-59
23-11-2012
31-10-2015
58
268.
M/s. Equinox Sales India
Limited, 2nd Floor, 202,
Moti Mahal, Dr. Annie
Besant Road, Worli, Naka,
Worli, Mumbai-400018
M/s. Equinox Medical
Technology B.V., De
Studam 25, 3815 KM,
Amersfoort, The
Netherland
1. Myriad/ Dental Implant
System
2.Unit/
Dental Implant System
31-603-MD/2009-DC
(Re Reg.01)
MD-603
23-11-2012
15-11-2015
269.
M/s. Excel Medinet Inc,
4/2390, Street N-11,
Govardha Bihari Colony,
Shahdara, Delhi-110032
M/s. Baumer S.A., Av.
Prefeito Antonio Tavares
Leite No. 181, Parque da
Empresa, Mogi Mirim/SP,
Brazil
1. Knee Prothesis/
Orthopaedic Implant
2. Hip Prothesis/
Ortjopaedic Implant
31-972-MD/2011-DC
MD-972
4-12-2012
15-11-2015
270.
M/s. Biomet Orthopaedics
India Pvt. Ltd., 2301,
Shanti Estate, Ghnasham
Estate, National Highway
No. 8, Aslali, Tal: Daskroi
(N.A.), AhmedabadGujarat
M/s. Biomet Orthopaedics
Switzerland GmbH,
having factory premises
at Riedstrasse 6, CH
8953Dietikon,
Switzreland
31-894-MD/2010-DC
MD-894
4-12-2012
15-11-2015
271.
M/s Vascular Concepts
Ltd., 7C Doddaballapur
Industrial Estate,
Doddaballapur, Bangalore561203.
31-1147-MD/2012-DC
MD-1147
4-12-2012
15-11-2015
272.
M/s Virbac Animal Health
India Pvt. Ltd., C&F M/s
Ergon Lab. Pvt, Ltd.,
APMC, Sanpada-N, Tal.
Sanpada (Thane-Zone 7)400705
M/s Medicut Stent
Technology GmbH,
having a factory premises
at Wilhelm Becker Str.,
11a,75179 Pforzheim
Germany
M/s. Elastec SRL, having
factory premises at
Boqueron 145, (1832)
Lomas de Zeroma,
Buenos Aires-Argentina
31-850-MD/2012-DC
MD-850
4-12-2012
15-11-2015
1. Biomet Bone
Cemnet R/ Bone
Cement (without
Antibiotic)
2. Refobacin Bone
Cement R/Bone
Cement(with
AntibioticGentamicin
Sulphate)
3.Biomet Bone
Cement V/Bone
Cement (without
Antibiotic)
1. Resistant/Self
Expandable
1. TRIU-B/ Progesterone
Impregnated intravaginal
59
273.
M/s Hester Diagnostics
Pvt. Ltd., Room No.9, 1st
Floor, 66, Princess Street,
Mumabi-400002.
274.
M/s. Covidien Healthcare
India Pvt. Ltd., “Doshi
Tower”, 6th Floor # 156,
Poonamallee High Road,
Killpauk, Chennai-600010
M/s Depuy Medical Private
Ltd., 64-66, Senapati
Bapat Marg, Mahim,
Mumbai-400016, India.
M/s. B. Braun Medical
(India) Pvt. Ltd., Bldg. No.
B, Gala No. 1-10, Prerna
Complex, Anjur Phata,
Dapoda Road, At Val
Village, Bhiwadi 421302,
Maharashtra
275.
276.
277.
278.
M/s. Cochlear Medical
Device Company India
Private Limited, Unit No.
G-3, Gr. Floor, Platina
Building, CTS. No. 4207
C-59, G-Block, Bandra
Kurla Complex, Bandra
(East), Mumbai, Tal:
Bandra East (MumbaiZone 4) - 400051
M/s. Kalyx India Health
M/s Merit Medical
Systems Inc., having a
factory premises at 1600
West Merit Parkway
South Jorden Utah
84095, USA
1. One step/ Percutaneous
Drainage catheter(centesis
catheters)
2. Percutaneous Access
Catheter
3. Merit/ Aspiration
Catheter(Embolectomy)/ASA
P 100
1. MarksMan/ Delivery
Catheter
31-1142-MD/2012-DC
MD-1142
4-12-2012
15-11-2015
31-51-A-MD/2006 DC (Rereg 2011) (End.05)
MD-51A
4-12-2012
14-05-2014
1. Summit/ Hip Replacement
System – Stem/ Model NoNil
31-852-MD/2010-DC
(End.1)
MD-852
4-12-12
31-01-2014
M/s. B. Braun Melsungen
AG, Carl-Braun-VietnamStraβe, 1,34212,
Melsungen, Germany
having factory premises
at M/s. B. Braun Vietnam
Co. Ltd., Thanh Oai
Industrial Complex,
Thanh Oai District,
156800 Hanoi, Vietnam
M/s. Cochlear Limited, 14
Mars Road, Lane Cove
NSW 2066, Australia
having factory premises
at M/s. Cochlear Limited,
1 University Avene,
Macquarie University,
NSW 2109, Australia
1. Sangofix/ Blood
administration sets vented
and non-vented
2. Intrafix Primeline, Intrafix
Safest/ I.V. Administration
Sets For pressure and
Gravity Infusion
31-1157-MD.2012-DC
MD-1157
5-12-2012
15-11-2015
1. Nucleus/ Cochlear implant
with straight electrode/Cl422
31-1089-MD/2012-DC
MD-1089
11-12-2012
15-11-2015
M/s European Medical
1. Genta C-Ment 1 & Genta
31-977-MD/2011-DC
MD-977
11-12-2012
30-11-2015
60
Care Pvt. Ltd., No.21, ‘F’
Block, Anna Nagar East,
Chennai-60 102, India
279.
M/s B. Braun Medical
(India) Pvt. Ltd, Bldg No.
B, Gala No. 1-10, Prerna
Complex, Anjur Phata,
Dapoda Road, Val Village,
Bhliwandi-42301,
Maharashtra.
280
M/s B. Braun Medical
(India) Pvt. Ltd, Bldg No.B,
Gala No. 1-10, Prerna
Complex, Anjur Phata,
Dapoda Road, Val Village
Bhiwandi-42301,
Maharashtra.
Contract Manufacturing
B.V. is having factory
premises at
Middenkampweg 14,6545
CH Nijmegen, Netherland
M/s. B. Braun Melsugen
AG, Carl-Braun Strasse
1, 34212 Melsungen,
Germany having
manufacturing premises
at M/s. B. Braun
Melsungen AG, Aesculap
Division, Vascular
Systems, Sieversufer
8,12359 Berlin, Germany
M/s B. Braun Melsugen
AG, Carl-Braun-Straβe
1,34212 Melsungen
Germany, having
manufacturing premises
at M/s Almo Ereugnisse
Erwin Bush GmbH,
Groβe, Allee 84-34454
C-Ment 3/Bone cement with
Gentamycin
2. C-Ment 1 & C- Ment
3/Bone cement (Without
antibiotic)
1.SeQuent Please/
Paclitaxel Releasing PTCA
Balloon Catheter Rapid
Exchange
2. PTCA Balloon Dilation
Catheter Rapid
Exchange/Model No.
SeQuebt, SeQuent II
3. Bare Metal Coronary
Stent System (Stainless
Steal)/ Model No. Coroflex
4. Bare ,Metal Coronary
Stent System (Cobalt
Chromium)/Model No.
Coroflex Blue, Coroflex Blue
Ultra, Coroflex Blue Neo
5. Coroflex Please/
Pavlitaxel Releasing
Coronary Stent System
(Stainless Steal)
6. Intradyn/ Puncture Needle
18 G/Model No. 5208505
7. Arteriofix/ Arterial
Catheter Set/ Model No.
5206316, 5206324,
5206332, 5206359
1.Hypodermic Syringe for
single use (without needle)/
Model No. Injickt Lucer Solo
2. Hypodermic Syringe for
single us e(with needle)/
Model No. 4645021-03,
4645023-03, 4645024-03,
4645122-03, 4645200V-03,
31-687-MD/2009-DC (Rereg-01)
MD-687
13-12-2012
30.11.2016
31-1138-MD/2012-DC
MD-1138
13-12-2012
31-12-2015
61
Bad Arolsen Germany
281.
M/s Teleflex Medical
Private Limited, Old No.
10, No. 19, 1st floor and
Ground floor, Harrington
Road, Chetpet, Chennai600031
M/s. Teleflex Medical
Sdn. Bhd., having factory
premises at Lot No. PT
2577, Jalan Perusahaan
4, 34600 Kumunting,
perak, Malaysia
282.
M/s Heily Medicare Exim
(P) Ltd., Door No.
XVI/1784/377-A,S-26,
Sankar Nagar, KollamKerala
M/s Ilerimplant S.L.
Poligono Industrial “
Elserge” C/Enginver Mies
705-B, 25191, Lleida
Spain
283.
M/s B. Braun Medical
(India) Pvt. Ltd, Bldg No.
4647220-03, 4647222-03,
4647240-03
3. Hypodermic Syringe for
single use (without needle)/
Model No. 4646200V-03
4. Hypodermic Syringe for
single use (without
needle)/Model No.916142603
5. Hypodermic Syringe for
single use (without
needle)/Model No.9161627,
9161627S, 9161635,
9161635S
1.Brilliant Balloon/Foley
Catheter(100%
Silicon)/Model
No.170605,170003
2. Sympacath/Hydrogel
Coated Trans-urethral
Catheter/ Model No.180530
3. Latex Poley Balloon
Catheter/ Model No.180003,
183430
4. Simplastic/ Trans-urethral
Balloon Catheter/ Model No.
664130
5.Endotracheal Tube/ Model
No.100382, 112082,
111780, 11781, 100380,
112482, 112480
1. Frontier/ Dental Implant
System-Implant
2. Frontier/Dental Implant
System-Abutments
3.Frontier/ Dental Implant
System-Screw
1. Dafilon®/ Polyamide
Monofilament Non
31-355-MD/2007-DC (Rereg-01)
MD-355
13-12-2012
30-11-2015
31-1107-MD/2012-DC
MD-1107
13-12-2012
31-11-2015
31-1093-MD/2012DC(Re-reg-01) (End.01)
MD-1093
13-12-2012
31-8-2015
62
284.
285.
B, Gala No. 1-10, Prerna
Complex, Anjur Phata,
Dapoda Road, Val Village,
Bhiwandi-42301,
Maharashtra.
M/s Cook India Medical
Devices Private Limited,
4/2449 A, Rashim
Enclave, P.H. Road,
Goparasanallur,
Kattupakkam, Chennai600056
M/s B. Braun Medical
(India) Pvt. Ltd, Bldg. No.
B, Gala No. 1-10, Prerna
Complex, Anjur Phata,
Dapoda Road, At Val
Village, Bhiwandi 421302,
Maharashtra
Absorbable Surgical Suture
M/s Cook Biotech
Incorporated, having a
factory premises at 1425
Innovation Plave, West
Lafayette, Indiana,
47906, USA
M/s. M/s. B. Braun
Melsungen AG having
factory premises at CarlBraun-Straβe, 1,34212,
Melsungen, Germany
1.Biodesign Surgisis/ Soft
Tissue Repair Grafts
2. Biodesign Surgisis/ Staple
Line Reinforcement
3. Biodesign Surgisis/ Anal
Fistula Plug
4. Biodesign Surgisis/ Dural
Graft
5.Biodesign Surgisis/
Uretheral Sling/Tension Free
Uretheral Sling
5. Biodesign Surgisis/
Anterior/ Posterior Pelvic
Floor Graft
1.Cavafix Range of
Catheters (Central Venous
Cathetr), Cavafix Certo/
Cavafix Certodyn/ Cavafix
Certo with Splittocan/
Cavafix MT/Cavafix Duo
2. Contiplex D Kit ( Needles
and Catheter Kits for Plexus
Anaesthesia)
3. Certofix Range of
Catheters (Central Venus
Cathetr), Certofix Mono/
Certofix Duo/ Certifix Duo
HF/ Certofix Trio/ Vertofix
Trio HF/ Certofix Quattro/
Certofix Quinto/ Certofix
Mono Paed/ Certofix Duo
Paed/ Certofix Trio Paed/
Certofix Protect Trio/
Certofix Protect Trio HF/
31-112-MD/2006-DC (Rereg 02)
MD-112
13-12-2012
14-01-2016
31-146-MD/2006-DC (Rereg 02)
MD-146
28-12-2012
30-11-2015
63
286.
287.
288.
M/s St. Jude Medical India
Pvt. Ltd. D. no.8-3168/B/1/18 & 19, Laxmi
Nagar MCH. Circle-V,
Hyderabad Dist.
M/s Katara Dental Pvt.
Ltd., P-14, I2IT Campus,
Ground Floor, Mithila
Hostel, Room No. 3, Rajiv
Gandhi Info Tech Park,
Hinjwadi, Pune-411057.
M/S Life Care Devices
M/s. BioHorizons Implant
Systems, Inc, Having
factory premises at 2300
Riberchase Center,
Birmingham, AL, 35244
USA
M/s Argon Critical Care
Certofix Protect Quattro/
Certofix Protect Quinto
4. Espocan (Catheter Sets
for Spinal/epidural
anaesthesia)
5. Infusion Kit for Visudyne
6. Perifix Range of Catheters
(Catheter for epidural
anaesthesia), Perifix / Perifix
Soft Tip/ Perifix Catheter/
Perifix One/ Perifix O ne
Paed/ Perifix One Catheter
7. Intrafix – IV Infusion Sets
Intrafix Primeline – IV
administration sets with air
vent for pressure gravity
infuseion,
Intrafix® Primeline – IV
administration sets with air
vent for gravity infusion,
Intrafix® Safeset – IV
administration sets with air
vent for pressure and gravity
infusion,
Intrafix® Safeset – IV
administration sets with air
vent for
1. Biocor/ Bovine Pericardial
Patch / Model No. B40
31-943-MD/2011-DC
(Endrosment-01)
MD-943
31-12-12
15-06-2015
1. BioHorizons/ Dental
Implant System (Titanium)
31-629-MD/2009-DC (Rereg.01)
MD-629
31-12-2012
31-12-2015
1. Secalon-T/ Central
31-1177-MD/2012-DC
MD-1177
31-12-2012
30-11-2015
64
289.
Privated Limited, Life Care
House, Yashodhan
Building Flat No.2, 2nd
Floor, 841 Mori Road,
Mahim (W) Mumbai400016
M/s St. Jude Medical India
Pvt. Ltd. D.NO. 8-3168/B/1, Plot No. 18 & 19,
Laxmi Nagar, Behind T.B
Hospital, MCH Circle-5
Mandal, Hyderabad.
Systems Singapore Pte.
Ltd., having factory
premises at 198 Yishun
Ave 7, Singapore 768926
Venous Catheter Kit/ Model
No. 681000,681002,
681004, 681006
M/s AGA Medical
Corporation having
factory premises at 5050
Lane North, Plymouth,
Minnesota, 55442 USA
1.AMPLATZER Septal
Occluder/ Cardiac Occluders
2.AMPLATZER MultiFenestrated Septal Occluder
– “Cribriform:”/ Cardiac
Occluders
3. AMPLATZER Duct
Occluder/Cardiac Occluder
4. AMPLATZER Duct
Occluder II/ Cardiac
Occluders
5. AMPLATZER Duct
Occluder II Additional Sizes/
Cardiac Occluders
6. AMPLATZER Vascular
Plug/ Cardiac Occluders
7. AMPLATZER Vascular
Plug II/ Cardiac Occluders
8. AMPLATZER Vascular
Plug III/ Cardiac Occluders
9. AMPLATZER Vascular
Plug 4/ Cardiac Occluders
9. AMPLATZER Cardiac
Plug/ Cardiac Occluders
10. AMPLATZER Cardiac
Plug/ Cardiac Occluders
Delivery Kit
11. AMPLATZER
Membranous VSD Occluder/
Cardiac Occluders
12. AMPLATZER Muscular
VSD Occluder/ Cardiac
Occluders Delivery Kit
31-1102-MD/2012-DC
MD-1102
31-12-2012
30-11-2015
65
290.
M/s Boston Scientific India
Pvt. Ltd., C-41, Ground
Floor, Okhla Industria l
Area, Phase-II, New Delhi20.
291.
M/s. Johnson and Johnson
Limited, J-1, Shree Arihant
Complex, Village Kalher,
Thane-Bhiwandi Rode,
Dist.- Thane, Bhiwandi
M/s Codman & Shurtleff
Inc., having factory
premises at 325
Paramount Drive,
Raynham,
Massachusetts, 027670350, USA
292.
M/s. DePuy Medical Pvt.
Ltd., Shed No. A1/50,
Paiki Room No. 1 to 9, 100
Shed Area, Degam Road,
G.I.D.C., Vapi 396195,
Taluka: Pardi, District:
Valsad, Gujarat
M/s M/s DePuy
Orthopaedics Inc. having
facto;ry premises at 700
Orthopaedic Drive,
Warsaw, In 46582, USA
293.
M/s Boston Scientific India
Pvt. Ltd., C-41, Ground
Floor, Okhla Industrial
13. AMPLATZER Post
Infaract Muscular VSD
Occluder/ Cardiac Occluders
14. AMPLATZER PFO
Occluder/ Cardiac Occluders
15. AMPLATZER TorqVue
LP-Catheter/ Cardiac
Occluders Deliver KIT
1. Blazer Prime HTD/
Temperature Ablation
Catheters (Cardiac)
2. Blazer Prime XP/
Temperature Ablation
Catheters (Cardiac)
1. CODMAN
MICROSENSOR/
Ventricular catheter kit with
ICP sensor/ Model No.
826653
2.Bactiseal/ VentriculoPeritonial Shunt/ Model No/
(82-8551, 82-8552, 82-8553)
1. DVR/Fracture Repair
System-Distal Volar Radius
(Non Sterile)
2. DNP/ Fracture Repair
System-Dorsal Nail Plating
(Non Sterile)
3. F3/ Fragment Planting
System ( Non Sterile)
4. S3/ Shoulder Flxation
System (Non Sterile)
5, SNP/ Shoulder Fixation
System-Shoulder Nail
Plating (Non Sterile)
1. Flexima APD/ All Purpose
Drainage Catheter System
2. Flexima APD/ All Purpose
31-1080-MD/2012-DC
(End.01)
MD-1080
31-12-2012
30-06-2015
31-121-MD/06-DC (Rereg-02)
MD-121
31-12-2012
14-01-2016
31-127-MD/2006-DC (Rereg 02)
MD-127
31-12-2012
15-12-2015
31-1037-MD/2011-DC
(End01)
MD-1037
31-12-2012
15-05-2015
66
Area, Phasse-II, New
Delhi-20
Drainage Catheter System
Kit
3.Flexima Quickstick/ All
Purpose Drainage Catheter
System
4. Flexima APDL/ All
Purpose Drainage Catheter
System Kit
5. Flexima APDL/ All
Purpose Drainage Catheter
System Kit
67