Registration Certificates issued for the Medical Devices alongwith their manufacturing sites and Indian Authorized
Agents from Jan. 2011 to August 2011
S. No.
Name of Indian Agent
Name of Manufacturer
Name of the Device
File No.
R. C. No.
1
M/s Sahajanand Medical
Technologies Pvt. Ltd.,
Sahajanand House, Parsi
Street, Saiyedpura, Surat395003, Indai
M/s VSY Ophthalmic
India Pvt. Ltd., 860/1-B,
GIDC Estate, Nr. ABB
Goods Gate, Makarpura,
Vadodara- 390010,
Gujarat
M/s. Natec Medical Ltd.,
Maeva Centre Building,
Business Park, Ebene,
Reduit, Maruitius
Catheter:
PTCA Catheter: Tamarin Blue (Non
Sterile)
31-273-MD/2007-DC
(Re-Registration 2009)
MD-273
Validity of the
Registration
Certificate
31-12-2013
ACRIVA Ultra Definition
Intra Ocular Lents
ACRIVA Reviol Multifocal
Intra Ocular Lens
OCUVA Aspheric Intra
Ocular Lens
OCUVA Spheric Intra Ocular
Lens
Open Pivot Heart Valve
Open Pivot Aortic Valved
Graft (AVG)
31-824-MD/2010-DC
MD-824
31-12-2013
31-892-MD/2010-DC
MD-892
31-12-2013
Intrafix-IV Infusion
administration sets vented
for pressure and gravity
infustions
31-146-MD/2006-DC
(Re-Registration 2009)
(End. 1)
MD-146
30-11-2012
2
M/s VSY BiotechnologyVSY Biyoteknoloji ve IIac
San. A.S. of Ataturk Mah.,
Sulun c., Kamilbey Sok
No. 4, Atasehir, Istanbul,
Turkey
1.
2.
3.
4.
3
M/s India Medtronic Pvt.
Ltd., 1241, Solitaire
Corporate Park, Building
Number 12, 4th Floor,
Anheri-Ghatkopar Link
Road, Andheri (E),
Mumbai- 400093
4
M/s B. Braun Medical
India Pvt. Ltd., 5th Floor,
East Quadrant, The IL &
FS Financial Centre,
Bandra Kurla Complex,
Bandra (E), Mumbai-
M/s Medtronic Inc., 710
Medtronic Parkway N. E.
Minneapolis MN 55432
USA having
manufacturing premises
at M/s Medtronic ATS
Medical Inc., 3905
Annapolis Lane, Suite 105
Minneapolis, MN – 5547,
USA
M/s B. B raun Melsungen
AG, Carl-Braun- Strasse 1,
34212 Melsungen,
Germany
1.
2.
1.
1
5
6
400051
M/s Edward Lifesciences
(India) Pvt. Ltd., E.F. 201204, Remi Biz Court, Plot
No. 9, Off Veera Desai
Road, Andheri West,
Mumbai- 400058
M/s Boston Scientific
International B.V., 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi- 110067
7
M/s Abbott Medical
Optics Pvt. Ltd., No. 91,
G.N.T. Road,
Madhavaram, Chennai600110
8
M/s B. Braun Medical
(India) Pvt. Ltd., 5 th
Floor , East Quadrant, The
IL & FS Financial Centre,
Bandra Kurla Complex,
Bandra (East), Mumbai400051
M/s Edward Lifesciences
LLC, One Edwards Way,
Irvine CA, USA 926145686
1.
Carpentier-Edwards
Bioprosthetic Valved
Conduit
Edwards MC Tricuspid
Annuloplasty System
31-93-MD/2006-DC (ReRegistration 2010) (End.
1)
MD- 93
31-01-2013
M/s Boston Scientific
Corporation, Boston
Scientific Place, Natick,
Massachusetts 017601537, USA having factory
premises at M/s Boston
Scientific Ireland Ltd.,
Ballybrit Business Park,
Galway, Ireland
M/s Abbott Medicals
Optics Inc., 1700E St.
Andrew Place, Santa Ana,
California 92705, USA
having factory premises
at M/s AMO
Manufacturing Spain, S.L.
Crta. Fuencarral A, KM
15.4, 28100 Alcobendas
(Madrid0, Spain
M/s B. Braun Medical,
204 Avenue du Marechal
Juin-BP 331, 92107
Boulogne, Cedex, France
having factory premises
at M/s B. Braun Medical
Industries Sdn. Bhd.,
Bayan Lepas Free
Industrial Zone, 11900
Penang, Malaysia
1.
WallFlex Enteral Colonic/
Duodenal Stent System
31-41A-MD/06-DC
(End. 2)
MD-41A
31-03-2013
1.
Blink Intensive Tears
31-737-MD/2009-DC
MD-737
31-12-2013
Needles for Implantable access ports
1. Surecan
2. Cytocan
31-393-MD/2007-DC
(Re-Registration 2010)
MD- 393
31-12-2013
2.
2
9
10
11
M/s RFCL Ltd., A-3,
Okhla Industrial Area,
Phase-I, New Delhi
M/s Epsilon Eye Care
Pvt. Ltd., 6B-301 Shweta
Asha Nagar, Western
Express Highway,
Kandivali East, Mumbai 400101
M/s Becton Dickinson
India Pvt. Ltd., 5th Floor,
Singnature Towers II,
South City-1, Gurgaon122001 Haryana
M/s Biokit S.A. Can Male
s/n, 08186, Llica d
Amunt, Barcelona, Spain
M/s Aaren Scientific Inc.,
4290 E. Brickell Street,
Building A, Ontario,
California 91761 USA
1.
Bioelisa HBsAg 3.0
6-6/CD-35/2009-DC
(Re-Reg 2009) (End 01)
CD-31
31-05-2012
1.
Oii PMMA (Intraocular
Lenses)
Oii Heparin PMMA
(Intraocular Lenses)
Oii Biovue (Intraocular
Lenses)
Alcohol Swab
31-14-MD/2006-DC (ReRegistration 2009)
MD-14
30-06-2012
31-825-MD/2010-DC
MD-825
14-12-2013
2.
3.
M/s Becton Dickinson
and Company, BD
Medical Diabetes Care, 1
Becton Drive, Franklin
Lakes, New Jersey 07417,
having factory premises
at M/s BD Medical
Diabetes Care, 1329 West
Highway # 6, Holdrege,
Nebraska, 68949, USA
M/s.KCI USA Inc., 4958
Stout Drive San Antonio,
TX 78219 USA having
factory premises at M/s
Polymedics BVBA, 1031
Ambachtslaan, Peer,
Belgium 3990
1.
1.
VAC WhiteFoam Small &
Large
31-792-MD/2010-DC
MD- 792
31-12-2013
12
M/s. Labindia Healthcare
Private Limited, 372
Udyog Vihar, Phase- 2,
Gurgaon, 122016,
Haryana
13
M/s. St. Jude Medical
India Private Limited,
A&B, 2nd Floor, “Brij
Tarang”, Greenlands,
Begumpet, Hyderabad
500016
M/s. St. Jude Medical,
14901 De Veau Place
Minnetonka, MN 553452126 USA
1.
Engage Family Introducers
31-22-MD/2006-DC (ReRegistration 2009) (End
3)
MD- 22
30-06-2012
14
M/s Baxter (India) Pvt.
Ltd., 2nd Floor, Tower C,
M/s Baxter Healthcare
Corporation 1900 N.
1.
Minicap Extended Life
Transfer Set
31-730-MD/2009-DC
MD- 730
31-12-2013
3
15
16
Building 8, DLF Cyber
City, DLF Phase II,
Gurgaon 122002
M/s Tyco Healthcare
India Pvt. Ltd., “DOSHI
TOWERS” 6th Floor,
Doshi twoers,
Poonamallee High Road,
Chennai- 600010
M/s. Globus Medical
India Private Limited,
New No. 3, Sriram Nagar,
South Street, Alwaret,
Chennai- 600018
Highway 201 Monutain
Home, ar 72653-2497
M/s Mediquip Sdn. Bhd.
PO Box 2501700 Kangar,
Perlis, Malaysia
1.
Kendall Curity Latex Foley
Catheter
31-333-MD/2007-DC
(Re-Registration 2010)
MD- 333
31-12-2013
M/s. Globus Medical,
Valley Forge Business
Centre 2560 General
Armistead Avenue
Andubon, PA 19403,
USA
1.
Microfuse Bone Void Filler
(Spine Indications), Sterile
H-Link Integrated Rod
Transition Stabilization
System STERILE Implant
Nilo Corpectomy Spacer
Patriot Singature TLIF
Spacer
Revolve Stabilization System
VIP Anterior Cervical Plate
System
Corridor Fixation System
Curved Applicator Tip 8cm
& 10cm
31-277-MD/2006-DC
(Re-Registration 2010)
(End 1)
MD- 277
28-02-2013
31-734A-MD/2009-DC
(Re-Registration 2011)
MD-734A
14-01-2014
31-441-MD/2008-DC
(Re-Reg. 2010)
MD-441
31-03-2014
2.
3.
4.
5.
6.
7.
17
M/s. Baxter India Private
Limited, 2nd Floor, Tower
C, Building 8, DLF Cyber
City, DLF Phase-II,
Gurgaon-122002
M/s. Baxter Healthcare
Corporation, 21026,
Alexander Court,
Hayward, CA 94545, USA
Having factory premises
at M/s. Baxter Healthcare
Corporation, 21026,
Alexander Court,
Hayward, CA 94545, USA
18
M/s. Smith & nephew
Healthcare Private
Limited, BG 1-3, 15-17
Rajlaxmi Commercial
Complex, kalher Village,
M/s. Smith & Nephew
Orthopaedics Limited, 1
Kingmaker Court,
Warwick Technology
Park, Gallows Hill,
8.
1.
Birmingham Hip Resurfacing System
4
Thane-Bhiwandi Road,
Thane-421302
19
M/s. Prime Surgicals,
3/15 Asaf Ali Road, New
Delhi-2
20
M/s. Alpha and Omega
Diagnostics India
Limited, Rajmahal 13,
Bhuleswar Road,
Mumbai-400002
M/s. DePuy Medical
private Limited, 64-66
Senapati Bapat Marg,
mahim, Mumbai-400016
21
22
M/s. WorldMed
Equipments Private
Limited, Office No. 49 &
50, 3rd Floor, Property no.
WZ 26, Village Nangli
Jalib, janak Puri, New
Delhi-110058
Warwick, CV34 6 WG,
UK having factory
premises at M/s. Smith &
Nephew Orthopaedics
Limited, Aurora Spa Park,
Harrison Way,
Leamington Spa,
Warwick, DV31 3HL, UK
M/s. Curamed
Opthalmics, Voorstraat
57, 4132 AN, Vianen,
Netherlands
M/s. Labotect GmbH,
labour technik-Gottingen,
Wille-Eicher Str. 25, D37079 Gottingen,
Germany
M/s. DePuy
Orthopaedics, Inc PO
BOX 988, 700 Orthopaedic
Drive, Warsaw, Indiana
46581-0988, USA having
factory premises at M/s.
Johnson & Johnson
Medical (Suzhou)
Limited, No. 299, Chang
Yang Street, Suzhou
Industrial Park, Suzhou
Jiangsu 215126, China
M/s. CID S.r.l., Strada per
Crescentino snc, 13040,
Saluggia (VC), Italy
Curamed Intraocular Lens
Hydrophilic Acrylic
31-152-MD/2006-DC
(Re-Reg. 2010)
MD-152
14-02-2014
Embryo Transfer Catheter
31-269-MD/2006-DC
(Re-Reg. 2010)
MD-269
14-02-2014
31-852-MD/2010-DC
MD-852
31-01-2014
31-06-MD/2006-DC (ReReg. 2009) (End 01)
MD-06
14-04-2013
1.
2.
3.
4.
5.
6.
7.
1.
2.
3.
PFC Tibial Trays-Standard &
Modular
Apex Hole Eliminator
Articul/Eze Heads
Duraloc Hip System-Poly
Liners & Cups
PFC Sigma Toal Knee
Replacement
Global Shoulder Systems
Screws: Cortical Screws,
Cancellous Screws and
pinnacle Screws
Janus Optima Carbostent
Brio Pegaso SCRX
Pro HP Pegaso
5
23.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
M/s. Johnson & Johnson
International, C/o
European Logistics
Centre, Lenneke
Marelaan 6, BE-1932 St
Stevens Woluwe, Belgium
having factory premises
at M/s. Johnson &
Johnson Medical GmbH,
Robert Koch Strasse 1, D22851 Norderstedt,
Germany
24.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
25.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
26.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
27.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
M/s. Medinol Limited,
PO Box 45026, Back Tech
Bldg, 4th Floor, HarHotzvim B, Hartom Street
8, Jerusalem 91450, Israel
M/s. Cordis Corporation,
14201, North West 60th
Avenue, Miami Lakes,
Florida 33014, USA
having factory premises
at M/s. Lake Region
Medical, 340 lake
Hazeltine Drive Chaska,
MN 55318, USA
M/s. Codman & Shurtleff
Inc, 325 Paramount Drive
Raynham, Massachusetts,
USA
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
1.
VICRYL Polyglactin 910
Violet Dyed and Undyed
Synthetic Absorbable
Sutures
2. VICRYL Plus Suture with
Triclosan
3. VICRYL Rapide Polyglactin
910 Violet Dyed & Undyed
Synthetic Absorbable
Sutures
4. PROLENE monofilament
Polypropylele Blue Dyed &
Undyed Synthetic nonabsorbable sutures
PRESILLION Plus CoCr Coronary
Stent on RX System (Sterile)
(PRESILLION Plus Stent System)
31-816 (FF-319)-MD/08DC (Re-Reg. 2011)
MD-816
(FF-319)
14-02-2014
31-788-MD/2010-DC
MD-788
14-02-2014
Emboli Capture Guidewire System:
Angioguard XP and Angioguard RX
31-859A-MD/2010-DC
MD-859A
31-01-2014
Duraform Dual Graft Implant
(Absorbable collagen-Sterile)
31-815 (A)- (FF-321)MD/2008-DC (Re-Reg.
2010)
MD-815 (A)
(FF-321)
31-03-2014
31-64-MD/2006-DC (ReReg. 2009)
MD-64
31-07-2012
1.
2.
Endeavor Zotarolimus
Eluting Coronary Stent
System
Endeavor-Sprint-
6
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
premises at M/s.
Medtronic Ireland
parkmore Business park,
West Galway, Ireland
3.
4.
28.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
29.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
30.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
premises at M/s.
Medtronic Ireland
parkmore Business park,
West Galway, Ireland
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
premises at M/s.
Medtronic Vascular 37A,
Cherry Hill Drive,
Danvers, MA 09123, USA
M/s. Medtronic Sofamore
Danek USA Inc, 1800
Pyramid Place, Memphis,
TN 38132, USA having
factory premises at M/s.
Medtronic Sofamore
Danek Manufacturing
2500, Silveus Crossing
Waresaw, Indiana, USA
1.
2.
1.
2.
Zotarolimus-Eluting RX
Coronary Stent System
Endeavor Resolute
Zotarolimus Eluting
Coronary Stent System
Assurant Cobalt Over-The
wire lilac Stent System
Talent Abdominal/AUI
Stent graft with Xcelerant
Hydro Delivery System
Valiant Stent Graft with
Xcelerant Delivery System
Launcher Guide Catheter
Vascular Diagnostic Catheter
(a) SiteSeer
(b) ProFlow
3. PTCA Guidewires
4. Angiographic Guidewires
5. Export and Export XT Aspiration
Catheters
6. Guardwire Occlusion and
Aspiration System
7. Woven Angiographic Catheters
8. Sherpa NX Guiding Catheters
1. Atlas Cable System
2. Brayan Cervical Disc System
3. MAV Motion Segment
Replacement-A-MAV & OMAV Artificial Disc
Replacement
4. LT-CAGE Lumber Tapered
Fusion Device
5. Prestige LP Cervical Disc
31-64-MD/2006-DC (ReReg. 2009) (PT-IV)
MD-64
31-07-2012
31-63-MD/2006-DC (ReReg. 2009)
MD-63
31-08-2012
31-69-MD/2006-DC (Rereg. 2009)
MD-69
31-01-2013
7
46582
System
ATLANTIS Anterior
Cervical Plate System
7. BASIS Spinal System
8. CD HORIZON Spinal
System
9. Pyramesh C Mesh
10. Pyramesh Implant System
11. Vertek Reconstruction
Implants
12. Zephir Anterior Cervical
Plate System
13. Dynamic Compression SMA
Stapple System
14. TSRH Spinal System
15. UCSS Universal Cannulated
Cortical Bone Screw
16. Colorado 2 Spinal System
Rashkind Septostomy Catheter
6.
31.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
32.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
33.
M/s. India Medtronic
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
premises at M/s. C.R.
Bard Inc, 289 Bay Road,
Queensbury, NY 12804,
USA
M/s. Medtronic Sofamore
Danek USA Inc, 1800
Pyramid Place, Memphis,
TN 38132, USA having
factory premises at M/s.
Medtronic Sofamore
Danek USA Inc, 4340
Swinnea Road, Memphis
TN 38118
M/s. Medtronic Inc, 710
31-341-MD/2007-DC
(Re-Reg. 2010)
MD-341
14-08-2013
Infuse Bone Graft
31-69B-MD/2006-DC
(Re-Reg. 2009)
MD-69B
14-04-2013
Total 5 Products
31-63-MD/2006-DC (Re-
MD-63
31-08-2012
8
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
34.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri East,
Mumbai-400093
35.
M/s. Allergan Healthcare
India Private Limited,
Level 2, Presige Obelisk,
No. 3 Kasturba Road,
Bangalore-560001
36.
M/s. KMS Medisurgi
Private Limited, 44,
Mangaldas Road,
Bulakhidas Building,
Ground Floor, Mumbai400002
M/s. S.R. International,
801, Manjusha, 57 Nehru
Place, New Delhi-110019
M/s. B. Braun Medical
India Private Limited, 5th
Floor, East Quadrant, The
IL & FS Financial Centre,
37.
38.
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
premises at M/s.
Medtronic vascular, 37A,
Cherry Hill Drivew,
Danvers, MA 09123, USA
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN 55432,
USA having factory
premises at M/s
Medtronic Ireland
parkmore Business Park
West Galway, Ireland
M/s. Allergan, 31, rue des
Colonnes du Trone,
75012, Paris, France
having factory premises
at M/s. Allergan Route de
promery, Zone Artisanale
de pre-Mairy, 74370
Pringy, France
M/s. Mascia Brunelli
s.p.a. Vle. Monza,
272.20128 Milano-Italy
M/s. Arcadophta Sarl, 11,
rue Antoine Ricord, 31100
Toulouse, France
M/s. B. Braun Melsungen
AG, Carl-Braun-Str. 1,
34212, Melsungen,
Germany having factory
Reg. 2009) (End 01)
Sprinter Legend Over the Wire
Balloon Dilatation Catheter
31-64-MD/2006-DC (ReReg. 2009) (PT-V)
MD-64
31-07-2012
Hyaluronic Acid with Lidocaine
31-483-MD/2008-DC
(End 01)
MD-483
31-05-2012
Haemostatic Gelatin Sponge
(Cutanplast)
6-4/FF/35/04-DC (PT)
(Re-Reg. 2010)
FF-276
31-01-2014
Arceole Set Multidose Kit (C3F7, SF6,
C2F6) (Intraocular Gases)
6-4/FF/40/06/DC (ReReg. 2010) (End 01)
FF-425
30-09-2013
Arteriofix-Arterial Catheter Sets
31-687-MD/2009-DC
(End 02)
MD-687
30-11-2012
9
Bandra Kurla Complex,
Bandra (E), Mumbai400051
39.
M/s. Boston Scientific
International B.V., 100A,
The Capital Court, Olof
Plame Marg, Murirka,
New Delhi-110067
premises at M/s. B. Braun
Melsungen AG, Vascular
Systems, Sieversufer 8,
12359, Berlin, Germany
M/s. Boston Scientific
Corporation, Boston
Scientific Place, Natick,
Massachusetts 017601537, USA having factory
premises at M/s.
Availmed S.A. de C.V. A.
Pasaeo Reforma No. 8950
Int. G1ByG1H, Col.
Fraccionamiento Rubio,
C.P. 22116, Le Mesa,
Tijuana, Baja, California
M/s. Smith & Nephew
Inc, Orthopedic
DEivision, 1450 Brooks
Road, Memphis, TN
38116, USA
40.
M/s. Smith & Nephew
Healthcare Private
Limited, C/O Shebros
Agencies, Minaxi
Industrial Estate, Gala-7,
Bldg-1, Naikpada, W.E.
Highway, Vasai9E),
Maharashtra-410208
41.
M/s. Baxter India Private
Limited, 2nd Floor, Tower
C, Building 8, DLF Cyber
City, DLF Phase-II,
Gurgaon-122002
M/s. Micromedics Inc,
1270 Eagen Industrial
Road, Suite #120 St. Paul,
MN 55121, USA
42
M/s. Baxter India Private
Limited, 2nd Floor, Tower
M/s. Baxter Healthcare
Corporation, 17511
1.
2.
3.
1.
2.
3.
4.
5.
Wiseguide Catheter
Impulse Angiographic
Catheter
Mach 1 Guide Catheter
Echelon Hip System
Synergy Hip System
Reflection Acetabular System
Genesis II Knee System
VersaBond and VersaBond
AB Bone Cements
6. Journey Knee System
7. Legion Knee System
8. Tandem Hip System
9. R3 Acetabular System
1. Duplospray MIS
Applicator[5mmX30cm,
5mmX40cm, 5mmX20cm,
20cm, 30cm]
2. Duplotip Dual Lumen
Cannula [20 GA X 10.4cm, 20
GA X 26.4cm, 5MMDia X
31.8cm]
Floseal Endoscopic Applicator
31-166-MD/2006-DC
(Re-Reg. 2009)
MD-166
14-02-2014
31-779-MD/2010-Dc
MD-779
14-02-2014
31-733-MD/2009-Dc
MD-733
31-01-2014
31-719-MD/2009-DC
MD-719
14-02-2014
10
43.
44.
45.
C, Building 8, DLF Cyber
City, DLF Phase-II,
Gurgaon-122002
M/s. Event Medi
Systems, 218 Vishal
Towers, District centre,
Janakpuri, New Delhi110058
M/s. Alcon Laboratories
India Private Limited,
Unit No. 502, Tower “D”,
5th Floor, RMZ Infinity,
Benniganahalli, Old
Madras Road, Bangalore560016
M/s. Edwards
Lifesciences India Private
Limited, E.F. 201-204
Remi Biz Court, Plot o. 9,
Off Veera Desai Road,
Andheri (W), Mumbai400058
Armstrong Avenue
Irvine, California 92614,
USA
M/s. Conic Vascular
Technology, SA Via G.
Curti, 5 CH-6900 Lugano,
Switzerland
M/s. Alcon Laboratories
Irelands Limited,m Cork
Business and technology
Park, Model Farm Road,
Cork Ireland
M/s. Edwards
Lifesciences Technology
Sarl, State Road 402, KM
1.4, Industrial Park,
Anasco, Puerto Rico
00610-1577
1.
2.
AcrySof IQ ReSTOR Multifocal
Intraocular lens
1.
2.
3.
4.
5.
6.
7.
46.
M/s. St. Jude Medical
M/s. Hansen Medical Inc,
Clever PTCA Balloon
Catheter
Conic One PTCA Balloon
Catheter
Advance venous Access
products
AVA 3Xi Devices
Central Venous Oximetry
Catheters (PreSep Oximetry
Catheters)
Swan-Ganz Cath Lab (NonThermodilution)
Swan-ganz Oximetry and
Volumetric Catheters
(Oximetry Catheters)
Swan-Ganz CCO and
CCOmbo Catheters (SwanGanz continuous cardiac
output (CCO))
Thermodilution Catheters
Fogarty Catheters
(Embolectomy) Catheters,
Thrombectomy Catheters,
Adherent Clot Catheter)
Artisan Control Catheter
31-798-MD/2010-DC
MD-798
31-01-2014
31-364-MD/2006-DC
(Re-Reg. 2010) (End 01)
MD-364
14-09-2013
31-91-MD/2006-DC (ReReg. 2009) (End 02)
MD-91
31-03-2013
31-812-MD/2010-DC
MD-812
31-01-2014
11
47.
48.
49.
50.
India private Limited, A
& B, 2nd Floor, Brij Tarang,
Greenlands, Begumpet,
Hyderabad-500016
M/s. Heart Beat
Intervention Private
Limited, 9, Lower
Ground, Narayan
Darshan Apartment, Opp.
Rupam Cinema,
Salabatpura, Surat395002, Gujarat
M/s. Access Devices, 28,
12th Cross, Indiranagar 1st
Stage, Bangalore-560038
M/s. Vishal Surgical
Equipment Co. Private
Limited, Melaram
Complex, 23, Wallers
Road, Chennai-600002
M/s. Evolutis India
Private Limited, 185-R,
Alhad, 1s Floor, P.K.
Road, Mulund (W),
Mumbai-400080
800 East Middlefield
Road, Mountain View CA
94043
M/s. Minvasys, 7, rue du
Fosse Blanc-92230
Genevilliers, France
M/s. Districlass Medical
SA, 16, Rue Paul Bert
42000 Saint EtienneFrance having factory
premises at M/s.
Districlass Medical SA,
B.P. 14, 69970 Chaponnay,
France
M/s. Gebruder martin
GmbH & Co, KG
Ludwigstaler Strasse 132,
78532 Tuttlingen,
Germany having factory
premises at M/s. Karl
Leibinger medizintechnik
GmbH & Co., KG,
Kolbinger Str. 10, D78570, Muelhelm
a.D./Germany
M/s. Evoluis, Avenue De
La Liberation-42720,
Briennon, France
1.
2.
3.
PTCA Catheters
PTA Catheters
Intra Coronary Stents
Districath Implantable Catheter Ports
1.
2.
3.
4.
Screws, Plates, mesh,
Distractors of various sizesTitanium
Resorbx Screws, Plates,
Mesh, Sonic-weld RX Pins
Screws, Plates, Mesh,
Distractors of various sizesTitanium
Screws, Plates, Mesh,
Distractors of various sizesStainless Steel
Total 8 products
31-275-MD/2007-D (ReReg. 2010)
MD-275
14-01-2014
31-97-MD/2006-DC (ReReg. 2010)
MD-97
14-02-2014
31-390-MD/2007-DC
(Re-Reg. 2010)
MD-390
14-02-2014
31-282-MD/2006-DC
(Re-Reg. 2010)
MD-282
14-02-2014
12
51.
52
53.
54.
55.
56.
M/s. Zimmer India
Privated Limited, Plot No.
B & B1, vanijya Nikunj, 7th
Floor, Enkay Tower,
Udyog Vihar, Phase-V,
Gurgaon-122016
M/s. Zimmer India
Privated Limited, Plot No.
B & B1, vanijya Nikunj, 7th
Floor, Enkay Tower,
Udyog Vihar, Phase-V,
Gurgaon-122016
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
M/s India Medtronic Pvt.
Ltd., 1241, Solitaire
Corporate Park, Building
Number 12, 4th Floor,
Anheri-Ghatkopar Link
Road, Andheri (E),
Mumbai- 400093
M/s. Hansraj Nayyar
Medical India, 1416,
Maker Chambers V,
Nariman Point, Mumbai400021
M/s. baxter India Private
Limited, 2nd Floor, Tower
C, Building 8, DLF Cyber
City, DLF Phase-II,
Gurgaon-122002
M/s. Zimmer GmbH,
Sulzer Allee 8, CH 8404,
Winterthur, Switzerland
Trofix Trochanteric Fixation Plating
System
31-171-MD/2006-DC
(Re-Reg. 2009) (End 01)
MD-171
31-07-2012
M/s. Zimmer GmbH,
Sulzer Allee 8, CH 8404,
Winterthur, Switzerland
Zimmer MMC Cup
31-171-MD/2006-DC
(Re-Reg. 2009) (End 02)
MD-171
31-07-2012
M/s. Ethicon LLC, Road
183 Km 8.3 San Lorenzo,
Puerto Rico 00754
M/s Medtronic Inc., 710
Medtronic Parkway N. E.
Minneapolis MN 55432
USA having
manufacturing premises
at M/s Medtronic Ireland
Parkmore Business Park
West Galway, Ireland
M/s. Smiths Medical ASD
Inc, 201 West Queen
Street, Southington,
Connecticut 06489, USA
1.
Prolene (Polypropylene) Soft
Mesh
2. Gynecare Gynemesh PS
Integrity Rapid Exchange Coronary
Stent System
31-738(A)-MD/2009-DC
End 01
MD-738(A)
28-02-2013
31-64-MD/2006-DC (ReReg. 2009) (End 06)
MD-64
31-07-2012
ProtectIV Plus Safety I.V. Catheter
31-809-MD/2010-DC
MD-809
14-02-2014
M/s. baxter Healthcare
SA, 8010 Zurich,
Switzerland having
factory premises at M/s.
Plan 1 Health Srl, Via
Solari 5, 33020, Amrao
(UD), Italy
Healthport Implantable Access Port
System (Venous, Arterial, Spinal)
31-159-MD/2006-DC
(Re-Reg. 2010)
MD-159
28-02-2014
13
57.
M/s. Advanced
Therapeutics Prtivate
Limited, Plot #1, 2nd
Floor, LSC New Rajinder
Nagar, New Delhi-110060
58.
M/s. TotipotentSC
Scientific Product Private
Limited, No. Y-23, 3rd
Street, Anna Nagar,
Chennai-600040
M/s. Teleflex medical
Private Limited, No. 19,
Harrington Road,
Chetpet, Chennai-600031
M/s. Yogi Kirpa MediChem Private Limited,
Amar Building, 355,56,
Central Avenue Road,
Chembur, Mumbai400071
M/s India Medtronic Pvt.
Ltd., 1241, Solitaire
Corporate Park, Building
Number 12, 4th Floor,
Anheri-Ghatkopar Link
Road, Andheri (E),
Mumbai- 400093
59.
60.
61.
M/s. Kaneka
Corporation, 2-4-3Chome, Nakanoshima,
Kita-ku, Osaka 530-8288,
Japan having factory
premises at M/s. Kaneka
medix Corporation,
kanagawa Plant, 225-1,
Aza Deguchi, Yamakita,
yamakita-MachiAshigara-Kami-Gun,
Kanagawa, 258-0113,
Japan
M/s. Thermogenesis
Corp., 2711 Citrus Road,
Rancho Cordova,
California-95742, USA
M/s. Willy Rusch GmbH,
Willy-Rusch-Strasse 4-10,
71394 Kernen, Germany
M/s. Heraeus Medical
GmbH, Philipp-Reis-Str.
8/13, 61273 Wehrheim,
Germany
M/s Medtronic Inc., 710
Medtronic Parkway N. E.
Minneapolis MN 55432
USA having
manufacturing premises
at M/s Medtronic Mexico
S. de R.L de C.V. Avenida
paseo del Cucapah 10510,
1.
2.
3.
4.
Throumbuster II
Fortis II (Balloon Catheter)
Crusade KMF0114A
Ichiban-Yari 380-1T, 380-3T
Res-Q 60 BMC
31-187-MD/2006-DC
(Re-Reg. 2011)
MD-187
28-02-2014
31-826-MD/2010-Dc
MD-826
28-02-2014
1.
2.
3.
4.
1.
2.
Tiemann Catheter
Deleforsse Catheter
Embolectomy Catheter
Silkolatex T-Tube
Bone Cement
Bone cement with
Gentamycin
31-776-MD/2010-DC
MD-776
28-02-2014
31-376-MD/2007-DC
(Re-Reg. 2010)
MD-376
31-03-2014
1.
Sprinter rapid Exchange
Balloon Dilatation Catheter
Sprinter legent RX Balloon
Dilatation Catheter
Melody Transcatheter
Pulmonary Valve
31-381-MD/2007-DC
(Re-Reg. 2010)
MD-381
14-02-2014
2.
3.
14
62.
M/s. Nobel Biocare India
Private Limited, 103AB,
1?f, Fortune 2000 bandraKurla Complex, bandra
(E), Mumbai-400051
63
M/s India Medtronic Pvt.
Ltd., 1241, Solitaire
Corporate Park, Building
Number 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri (E),
Mumbai- 400093
64.
M/s. Faith Biotech Private
Limited, E-107, Lajpat
Nagar,-1, New Delhi110024
M/s. baxter India Private
Limited, 2nd Floor, Tower
C, Building 8, DLF Cyber
City, DLF Phase-II,
Gurgaon-122002
M/s. Lifetech Scientific
India Private Limited, #3,
1st Main, 3rd Floor, BDA
Layout, Kodihally, HAL
2nd Stage, Bangalore560008
65.
66.
67.
M/s. Johnson & Johnson
Parque Industrial EI Lago,
Tijuana, B.C. 22570<
Mexico
M/s. Nobel Biocare USA
LLC 22715 Savi Rusch
Parkway Yorba Linda,
CA 92887
M/s Medtronic Inc., 710
Medtronic Parkway N. E.
Minneapolis MN 55432
USA having
manufacturing premises
at M/s Medtronic Ireland
Parkmore Business Park
West Galway, Ireland
M/s. Micro Vention Inc,
1311 Valencia Avenue,
Tustin, CA, USA 92780
M/s. Baxter Healthcare
Corporation, 21026,
Alexander Court,
Hayward, CA 94545, USA
M/s. Lifetech Scientific
(Shenzhen) Co. Limited,
Floor 3-1 Cybio Electronic
Building, Langshan 2nd
Street, North Area of
High-Tech Park, nanshan
District, Shenzhen,
518057, China
M/s. Ethicon Inc, Route
Total 6 Products
31-218-MD/2007-DC
(Re-Reg. 20100
MD-218
28-02-2014
Complete SE lilac Stent System
31-64-MD/2006-DC (Rereg. 2009) End 4
MD-64
31-07-2012
Microplex Coil System
(MCS)
2. Hydro Coil Embolic System
(HES)
Total 2 products
31-804 (A)-MD/2010DC
MD-804(A)
14-03-2014
31-686(B)-MD/2009-DC
(Re-Reg. 2010)
MD-686(B)
14-03-2014
Total 4 Products
31-834-MD/2010-DC
MD-834
14-03-2014
Proceed Surgical Mesh
31-827-MD/2010-DC
MD-827
14-03-2014
1.
15
Limited, 30, Forjett Street,
Mumbai-400036
68.
69.
M/s. Zimmer India
Private Limited, Plot No.
B & B1, Vanijya Nikunj,
7th Floor, Enkay Tower,
Udyog Vihar, Phase-V,
Gurgaon-122016
M/s. Ophtho Equip Inc,
703, Samrueddhi, Opp.
Sakar-III, Nacrangpura,
Ahmedabad-380014
70.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri (E),
Mumbai-400093
71.
M/s. Teleflex Medical
Private Limited, 64,
Rukmani Lakshmipathi
Salai, (20 Marshalls
Road), Egmore, Chennai600008
22 West Somercille New
Jersy 08876, USA having
factory premises at M/s.
Ethicon Inc, 655 Ethicon
Circle, Cornelia, Georgia
30531, USA
M/s. Zimmer GmbH
Sulzer Allee 8, CH 8404
Winterthur, Switzerland
M/s. Staar Surgical Co.
1911 Walker Avenue,
Monrovia, CA 91016,
USA having factory
premises at M/s. Staar
Surgical AG, Hauptsrasse
104, 2560 Nidau,
Switzerland
M/s. Medtronic Sofamore
Danek Inc, 1800 Pyramid
Place, Memphis, TN
38132, USA having
factory premises at M/s.
Medtronic Sofamor
Danek Deggendorf
GmbH, Werftstr 17, 94469
Deggendorf, Germany
M/s. Arrow International
Inc, 2400 Bern Ville Road
reading Pennsylvanta
19605, USA having
factory premises at M/s.
Arrow International Inc
(Subsidiary of Arrow
1.
2.
Metasul Taper Liner
Biolox Delta Taper Liner
31-171-MD/2006-DC
(Re-Reg. 2009) End 01
MD-171
31-07-2012
STAAR PHAKIC IOL-Collamer
Implantable Contact Lens
(ICL/TICL)
31-926-MD/2011-DC
MD-926
14-03-2014
VERTE STACK-Spinal System
(a) Capstone Vertebral Body
Spacer
(b) Cornerstone PSR Peek
Implants
31-69A-MD/2006-DC
(Re-Reg. 2009)
MD-69A
14-03-2014
Intra Aortic Balloon (IAB) Catheters,
Sterile
31-841-MD/2010-Dc
MD-841
14-03-2014
16
International inc) 9
Plymouth Street Everett,
Massachusetts 02149,
USA
M/s. Tecres SpA, Via
Andrea Doria 6 37066
Sommacampagna-VRItaly
72.
M/s. MN Solutions, #26
& 27, 2nd Floor, WZ-26,
Nangli Jalib, B-1, Janak
Puri, New Delhi-110058
73.
M/s. Nobel Biocare India
Private Limited, 103AB,
1/F, Fortune 2000,
Bandra-Kurla Complex,
bandra (E), Mumbai400051
M/s. Nobel Biocare AB,
P.O. Box No. 5190, SE40226, Goreborg, Sweden
having factory premises
at M/s. Nobel Biocare AB,
Dimbovagen 2, SE-691 51
Karlskoga, Sweden
74.
M/s. Hemant Surgical
Industries Limited, 647,
Avijah Building, Ground
Floor, No. 6 & 7, Girgaum
Road, Mumbai-400002
75.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Kalyx India
Healthcare Private
Limited, No. 21, ‘F’ Block,
Anna Nagar East,
Chennai-600102
M/s. Shanghai Kindly
Enterprise Developmetn
Group Co. Limited, No.
18 Lan,e 668 Haujiang
Road, 201803, Shanghai,
China
M/s. Sofradim
Production 116 Avenue
du Formans F-01600
Trevoux, Frnace
76.
M/s. AAP Implantate
AG, Lorenzweg 5 D-12099
Berlin, Germany
1. Cemex
2. Cemex Genta
3. Spacer
4. Spacer
5. Mendec
Dental Implants
1. Nobel Active (Titanium)
2. Branemark System
(Titanium)
3. Zygoma (Titanium)
4. Nobel Replace (Titanium)
5. Nobel Speedy (Titanium)
6. Nobel Esthetics (Titanium)
7. Procera
1. Scalp Vein Set
2. Hypodermic Needles
3. Syringes
31-818-MD/2010-Dc
MD-818
14-03-2014
31-217-MD/2007-DC
(Re-Reg)
MD-217
31-03-2014
31-854-MD/2010-Dc
MD-854
14-03-2014
Parietex
Parietex Composite
Parietene
Parietene Composite
31-933-MD/2011-Dc
MD-933
14-03-2014
Medical Device Family: Bone Plates,
Bone Screws & Wire, Bone Kit
31-835-MD/2010-DC
MD-835
31-03-2014
a.
b.
c.
d.
17
77.
78.
79.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame, Marg, Munirka,
New Delhi-110067
M/s. Alcon Laboratories
India Private Limited,
Unit No. 502, Tower “D”,
5th Floor, RMZ Infinity,
benniganahalli, Old
Madras Road, Bangalore560016
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building Number 12, 4th
Floor, Andheri-Ghatkopar
Link Road, Andheri (E),
Mumbai-400093
80.
M/s. MN Solutions, #26
& 27, 2nd Floor, WZ-26,
Nangli Jalib, B-1, Janak
Puri, New Delhi-110058
81.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
82.
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
M/s. Boston Scientific
Corporation, Boston
Scientific Palace, Natick,
Massachusetts 017601537, USA
M/s. Alcon Research
Limited, 714 Columbia
Avenue, Sinking Spring,
Pennsyllvania, 19608,
USA
Wingspan Stent System
31-165-MD/2006-DC
MD-165
14-06-2013
Alcon Non-Absorbable Surgical
Suture
31-875-MD/2010-Dc
MD-875
31-03-2014
M/s. Medtronic Ireland,
parkmore Business park,
West Galway, Ireland
having factory premises
at M/s. Medtronic Inc,
710 Medtronic Park Way,
NE Minneapolis, MN55432, USA
M/s. Biomatlante, 5 rue
Edouard belin, ZA Les
Quatre nations, 44360,
Vigneux de Bretagne,
France
M/s. Covidien IIc, 15
Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s.
Mallinckrodt Medical,
Commaddy, Athlone Co.
Westmeath, Ireland
M/s. Cordis Cashel, Cahir
Road, Cashel Co.
Tipperary Ireland having
Raliant Stent Graft Balloon Catheter
31-64-MD/2006-DC (ReReg. 2009) End 07
MD-64
31-07-2012
Bone X (Calcium Phosphate Bone
Substitute)
31-800-MD/2010-DC
MD-800
31-03-2014
31-419-MD/2008-DC
(Re-Reg. 2011)
MD-419
14-04-2014
31-881-MD/2010-DC
MD-881
14-04-2014
1.
2.
3.
Endobronchial Tubes
Tracheal Tubes
Tracheostomy Tubes
Total 13 products
18
Kalher, Thane-Bhiwandi
Road, Distt-Thane,
Bhiwandi
83.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
84.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
85.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
86.
M/s. Covidien Healthcare
India Private Limited,
factory premises at M/s.
Cordis de Mexico SA, de
CV Calle Circuito Interior
Norte # 1820, Parque
Industrial Salvarcar,
Ciudad Juarez,
Chihuahua, mexico 32575
M/s. Covidien IIc, 15
Hampshire
Street,
Mansfield, MA 02048,
USA
having
factory
premises
at
M/s.
Mallinckrodt DAR, via G
Bove 2/4/6/8, 41037,
Mirandola (MO), Italy
M/s. Covidien IIc, 15
Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s.
Covidien, 5439 State
Route 40 Argyle, NY
12809, USA
M/s. Kendall Kenmex, A
Division of Tyco
Healthcare Group LP, 15
Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s. Tyco
Healthcare Group LP,
Calle 9 Sur No. 125,
Ciudad Industrial
Tijuana, Mexico CP 22500
M/s. Kendall, A Division
of Tyco Healthcare Group
Closed Sunction System with
accessories (Replaceable catheter,
Pediatric, Neonatal)
31-418-MD/2008-DC
(Re-Reg. 2011)
MD-418
31-03-2014
Total 9 products
31-50-MD/2006-DC (ReReg. 2011)
MD-50
31-03-2014
Trocar Catheters
Thoracic Catheters
31-47-MD/2006-DC (ReReg. 2011)
MD-47
31-03-2014
1.
31-49-MD/2006-DC (ReReg. 2011)
MD-49
31-03-2014
1.
2.
100% Silicone Folley
catheters
19
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
87.
88.
89.
90.
M/s. MIV Therapeutics
India Private Limited,
136-B, Surat Special
Economic Zone, Road No.
4, Diamond Park, GIDC,
Sachin, Surat-394230
M/s. Advanced
Lifesciences Private
Limited, D-22, Okhla
Industrial Area, Phase-I,
New Delhi-110020
M/s. Advanced
Lifesciences Private
Limited, D-22, Okhla
Industrial Area, Phase-I,
New Delhi-110020
M/s. Teleflex medical
Private Limited, Old No.
10, No. 19, Harrington
Road, Chetpet, Chennai600031
LP, 15 Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s. nellcor
Puritan Bennett Mexico
SA de CV, 37 blvd,
Insurgentes, Libramiento
a la P, La Mesa, Tijuana,
BC, Mexico
M/s. Natec Medical
Limited, maeva Centre,
Business park, Ebene,
Reduit, Mauritius
M/s. Merit Medical
Systems Inc, 1600 West
Merit parkway, South
Jordan, Utah 84095, USA
having factory premises
at M/s. Merit Medical
Systems Inc, 1111 South
Velasco, Angleton, Texas
77515, USA
M/s. Merit Medical
Systems Inc, 1600 West
Merit parkway, South
Jordan, Utah 84095, USA
M/s. Arrow International
Inc, 2400 Bern Ville Road,
Reading Pennsylyania
19605, USA having
factory premises at M/s.
Arrow International inc,
312 Commerce Palace,
2.
1.
Silison Thoracic Catheter
Tamarin Blue (Non-Sterile)
PTCA Catheter
Filao Rx (Non Sterile) PTCA
Catheter
31-326-MD/2007-DC
(Re-Reg. 2010)
MD-326
31-03-2014
31-158-MD/2006-DC
(Re-Reg. 2009)
MD-158
31-03-2014
4.
Diagnostic Angiographic
Catheters-Performa
Diagnostic Angiographic
Catheters-Softuch
Diagnostic Angiographic
Catheters-Impress
Guide Catheters-Concierge
1.
2.
Infusion Catheters-Fountain
Infusion Catheters-Mistique
31-937-MD/2011-Dc
MD-937
31-03-2014
31-844-MD/2010-Dc
MD-844
31-03-2014
2.
1.
2.
3.
Total 8 products
20
91.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
92.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
93.
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Bhiwandi
94.
M/s. Abbott Medical
Optics Private Limited,
Asheboro, North Carolina
27203, USA
M/s. ev3 Inc, 4600
Nathan Lane North,
Plymouth, MN 55442,
USA
M/s. ev3 Inc, 4600
Nathan Lane North,
Plymouth, MN 55442,
USA having factory
premises at M/s. Micro
Therapeutics Inc, d/b/a
ev3 Neurovascular Inc,
9775 Toledo Way, Irvine,
CA 92618, USA
M/s. Biosense Webster
Inc, 3333 Diamond
Canyon Road, Diamond
Bar, CA 91765, USA
having factory premises
at M/s. Siemens Limited,
Seoul, Pohang
Technopark, 601, Jigok
dong, Nam-gu, Pohang-si,
2nd & 3rd venture Blvd,
Gyeongsangbuk-do 790834, Republic of Korea
M/s. Abbott Medical
Optics Inc, 1700 E. St.
1.
2.
Protégé
ParaMount Mini GPS Stent
System
3. SpideFx
4. Goose Neck Snare catheters
5. VisiPro Balloon Expandable
Biliary Stent System
6. NanoCross .014 OTW PTA
Dialation Catheter
7. EverCross .035” OTW PTA
Dialation catheter
SilverHawk Peripheral Plaque
Excision
31-51-MD/2006-DC (ReReg. 2011)
MD-51
31-03-2014
31-624-MD/2009-DC
(Re-Reg. 2011)
MD-624
31-03-2014
SoundStar 3D Diagnostic Ultrasound
Catheter
31-898-MD/2010-Dc
MD-898
14-04-2014
Tecnis Multifocal 1-Piece Intraocular
Lens (Model: ZMB00)
31-17-MD/2006-DC (Rereg.) End 01
MD-17
31-05-2013
21
No. 91, G N T Road,
Madhavraman, Chennai600110
95.
M/s. Cure Surgicals, S-12,
1st Floor, Green park
Extension, Opp. Uphaar
Cinema, New Delhi110016
96.
M/s. Clairvoyance
Consulting, Flat No. 801,
8th Floor, Indra Prakash
Building, 21, Barakhamba
Road, Connaught Place,
New Delhi-110001
M/s. Cure Surgicals, S-12,
1st Floor, Green park
Extension, New Delhi110016
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
97.
98.
99.
M/s. Covidien Healthcare
India Private Limited,
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. Biosomposites
Limited, Keele Science
Park, Keele Newcastle
Under Lyme,
Staffordshire, STS 5 NL,
England
M/s. Invatec Technology
Centre GmbH,
Hungerbuelstrasse 12a,
8500 Frauenfeld,
Switzerland
M/s. Synergie Ingenierie
Medicals-S.A.R.L., Z.A.
de L’Angle 19370
Chamberet-France
M/s. Covidien IIc, 15,
Hampshire Street,
Mansfield, MA 02048,
USA having factory
premises at M/s.
Covidien Zona Frnaca de
san Isidro, Santo
Domingo, Dominican
Republic
M/s. Covidien IIc, 15
Hampshire Street,
1.
Genex-Bone void filler/Bone
Graft Substitute
2. Stimulan-Bone void
filler/Bone Graft Substitute
3. Allogran-R-Bone void
filler/Bone Graft Substitute
4. Allogran-N-Bone void
filler/Bone Graft Substitute
IN.PACT Falcon (Rx & OTW)Paclitaxel-eluting Balloon Dilatation
PTCA Catheter
31-402-MD/2007-DC
(Re-reg. 2011)
MD-402
30-06-2014
31-833-MD/2010-Dc
MD-833
31-03-2014
1.
2.
Bio Fix Spacer
Bio Fix (VTP, 3, 3G, 1, 1G,
PR, PR3G & Carnioplasty)
31-666-MD/2009-DC
MD-666
14-04-2014
1.
2.
3.
Ticron
Polysorb Lactometer
Steel 316L Stainless Steel
Suture
Flexon temporary Cardiac
Pacing Lead
31-948-MD/2011-DC
MD-948
14-04-2014
31-949-MD/2011-DC
MD-949
14-04-2014
4.
Total 9 products
22
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
100.
M/s. Abbott Healthcare
Private Limited, 4,
Corporate Park, Sion
Trombay Road, Chembur,
Mumbai-400071
101.
M/s. Abbott Healthcare
Private Limited, 4,
Corporate Park, Sion
Trombay Road, Chembur,
Mumbai-400071
102.
M/s. Hansraj Nayyar
Medical, 1416 Maker
Chambers V, 14th Floor,
Nariman Point, Mumbai400021
103.
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Mansfield, MA 02048,
USA having factory
premises at M/s.
Covidien 60, Middletown,
Avenue, North Haven,
CT 06473, USA
M/s. Abbott Vascular,
3200 Lakeside Drive,
Santa Clara, California
95054, USA having
factory premises at M/s.
Abbott Vascular, 26531
Yenz Road, Temecula,
California 92591, USA
M/s. Abbott Vascular,
3200 Lakeside Drive,
Santa Clara, California
95054, USA having
factory premises at M/s.
Abbott Vascular, 26531
Yenz Road, Temecula,
California 92591, USA
M/s. Smiths Medical ASD
Inc, 10, Bowman Drive,
Keene, NH 03431 0724,
USA having factory
premises at M/s. Smiths
Medical International
Limites, St. Crisping Way,
Haslingden, Rossendale,
Lancashire, BB4 4PW, UK
M/s. Ethicon sarl, Puits
Godet 20, 2000 Neuchatel,
Switzerland
NC TREK Coronary Dilatation
Catheter Product Family
(NC TREK RX)
31-307-MD/2007-DC
(Re-Reg. 2010) (End 01)
31-307
30-06-2013
Absolute PRO peripheral SelfExpanding Stent System Family
31-256A-MD/2006-DC
(Re-Reg. 2010) (End 01)
MD-256A
30-04-2013
Epidural Catheter
31-830-MD/2010-DC
MD-830
14-04-2014
31-845-MD/2010-DC
MD-845
31-04-2014
1.
2.
3.
Gynecare TVT Exact
Continence System
Gynecare TVT ABBREVO
Continence System
Gynecare PROSIMA Pelvic
23
104.
105
106
Bhiwandi
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Bhiwandi
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building No. 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri East,
Mumbai-400093
M/s. Boston Scientific
International BV, C-40,
Okhla Industrial Area,
Phase-II, New Delhi110020
107
M/s. Smith & Nephew
Healthcare Private
Limited, Building 2-3 &
15-17 Rahlaxmi Complex,
Opp. Hanuman Bus Stop,
Kalher, Thane-Bhiwandi
Road, Thane-421302
108
M/s. Avana Medical
Devices Private Limited,
M/s. Mentor Medical
Systems B.V.,
Zernikedreef 2, 2333 CL
Leiden, The Netherlands
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN-55432,
USA having factory
premises at M/s.
Medtronic Ireland
Parkmore Business Park
West, Galway, Ireland
M/s. Boston Scientific
Corporation, One Boston
Scientific Place, Natick
Massachusetts 017601537, USA having factory
premises at M/s. Boston
Scientific Cork Limited,
Business & Technology
Park, Model Farm Road,
Cork, Ireland
M/s. Smith & Nephew
Inc, 1450, Brooks Road,
Memphis Tennessee
38116, USA having
factory premises at M/s.
Smith & Nephew
Orthopaedics GmbH,
Alemannenstrasse 14,
Tuttlingen, Germany
M/s. Arthrex Inc, 1370
Creekside Boulevard,
Floor Repair System
Gel Breast Implant-Cohesive I,
II, III Smooth/Siltex./CPG
2. Becker Expanders/Breast
Implants
3. Spectra Adjustable Gel Breast
Implants
Resolute Integrity Zotarolimus
Eluting Coronary Stent System
1.
31-884-MD/2010-DC
MD-884
30-04-2014
3164-MD/2006-DC (ReReg. 2009) End 08
MD-64
31-07-2012
31-163-MD/2006-DC
(Re-Reg. 2009) (End 01)
MD-163
31-03-2013
CPCS Hip[ System
31-858-MD/2010-Dc
MD-858
14-04-2013
Total 4 drugs
31-846-MD/2010-DC
MD-846
14-04-2014
1.
2.
Neuroform EZ Stent
Delivery System
Neuro Renegade Hi-Flo
Microcatheter
24
109
110
111.
112.
2nd Floor, N6D.O. 14.D,
Viswanathan Street, West
Mambalam, Chennai600033
M/s. Teleflex Medial
private Limited, Old No.
19, 1st Floor, & Ground
Floor, Harrington Road,
Chetpet, Chennai-600031
M/s. Biotronik Medical
devices India Private
Limited, 101-106, Plot No.
14, LSC, Kalkaji, New
Delhi-110019
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Bhiwandi
M/s. 3M India Limited,
Plot Nos 48-51, Electronic
City, Hosur Road,
Bangalore-560100
Naples, Florida, USA
34108-1945
M/s. Arrow International
Inc, 2400 Bern Ville Road,
Rading Pennsylkvania
19605, USA having
factory premises at M/s.
Arrow International de
Chihuahua S.A. de C.V.
Modulo1, Circuito 5,
Parque Industrias de
America Col.
Panamericana,
Chihuahua 31200 Mexico
M/s. Biotronik AG,
Ackerstasse 6, 8180
Bulach, Switzerland
M/s. Ethicon LLC, 475 C
Street, Los Frailes
Industrial Park, Suite 401,
Guaynabo 00969, Puerto
Rico, USA having factory
premises at M/s. Ethicon
Inc, Calle Durango No.
2751 Lote Bravo, Ciudad
Juarez, Chihuahua, C. P.
32575, Mexico
M/s. 3M Healthcare Care,
St. paul, MN 55144-1000,
USA having factory
premises at M/s. 3M
Deutschland
1.
2.
3.
4.
Central Venous Catheter
Arterial Catheters and
Accessories, Sterile
Percutaneous Sheath
Introducers and accessories
sterile
Spring wire guide and
accessories, sterile
31-842-MD/2010-DC
MD-=842
14-04-2014
Total 8 drugs
31-461-MD/2008-DC
(Re-Reg. 2010)
MD-461
30-04-2014
31-798(A)-MD/2010-DC
MD-798(A)
30-04-2014
31-710 (C )-MD/2009DC
MD-710 (C
)
30-04-2014
Total 13 drugs
1.
2.
3M Tegaderm IV
Transparent Film Dressing
with Border
3M Tegaderm IV
Transparent Film Dressing
25
113.
M/s. Covidien Healthcare
India Private Limited,
Doshi Towers, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
114.
M/s. Covidien Healthcare
India Private Limited,
Doshi Towers, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Teleflex Medial
private Limited, Old No.
19, 1st Floor, & Ground
Floor, Harrington Road,
Chetpet, Chennai-600031
M/s. becton Dickinson
India private Limited, 5th
Floor, Signature Towers,
II, South City 1, Gurgaon122001
115.
116.
117.
M/s. Globe Biomedicals,
Room C/2, Juhu
Apartment, Near S.N.D.T.
GmbH/Medical
manufacturing Kamen,
Edisonstrasse 6, Kamen,
Germany 59157
M/s. Covidien Inc, 15
Hampshire Street,
Mansfield MA 02048,
USA having factory
premises at M/s.
Covidien Building 911-67
Sabanetas Industrial Park,
Ponce, Puerto Rico 00731,
USA
M/s. Tyco Healthcare
Ireland Limited, Sragh
Industrial Estate,
Tullamore County,
Ofally, Republic of
Irlenad
M/s. Willy Rusch GmbH,
Willy-Rusch-Strasse 4-10,
71394, Kernen, Germany
M/s. Becton Dickinson
and Company, 1 Becton
Drive, Franklin Lakes, NJ
07417, USA having
factory premises at M/s.
BD Medical Surgical,
1852, 10th Avenue,
Columbus, NE 68601,
USA
M/s. Dongguan Kewei
Medical Instruments Co.
Limited, Shijing Industrial
with Frame Style
Helical Fasteners
1.
2.
Trocar Catheters
Thoracic Catheters
RUSCH, ENDO TRACHEAL TUBES
31-796-MD/2010-DC
(Re-Reg. 2011)
MD-796
30-04-2014
31-46-MD/2006-DC (ReReg. 2011)
MD-46
30-04-2014
31-776-MD/2010-DC
(End 01)
MD-776
28-02-2014
1.
2.
BD Blunt Fill Needles
BD Blunt Fill Needles with
Filter
31-669 (B)-MD/2009-DC
(End 01)
MD-699(B)
14-01-2013
1.
2.
3.
Amender ASD Occluders
Amender PDA Occluders
Amender VSD Occluders
31-821-MD/2010-DC
MD-821
14-05-2014
26
College , Juhu, Mumbai
400049, Maharashtra
118.
119.
120.
121.
122.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. becton Dickinson
India Private Limited, No.
34, Assisi Nagar, West
Thottam, Madhavaram,
Chennai-51
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Smart Ortho
Devices Private Limited,
#3, Park View-I, Sohna
Road, Gurgaon
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai-
Zone, Tongsha
Technology Park,
Dongcheng District,
Dongguan City,
Guangdong Province,
China
M/s. Micro Therapeutics
Inc, d/b/a ev3
Neurovascular, 9775
Toledo Way, Irvine, CA
92618, USA
M/s. Becton Dickinson
and Company, 1 Becton
Drive, Franklin Lakes, NJ
07417, USA having
factory premises at M/s.
BD Caribe Limited, Road
31 KM 24.3 PO Box 4010,
Juncos, Puerto Rico 007774010, USA
M/s. Covidien IIc, 15
Hampshire Street,
Mansfield, MA 02048,
USA
M/s. ABS Corporation
Inc, 5909 Baker Road,
Suite 550, Minnetonka,
MN 55345, USA
M/s. Mediquip Sdn. Bhd,
PO Box 25, 01700 Kangar,
Perlis, Malaysia
Total 12 Drugs
31-51A-MD/2006-DC
(Re-Reg. 2011)
MD-51A
14-05-2014
31-819-MD/2010-DC
MD-819
14-05-2014
Palindrome H Chronic
Catheter Kit
2. Palindrome SI Chronic
Catheter Kit
3. Palindrome HIS Chronic
Catheter Kit
OrthoGlide Medical Knee Implant
31-50-MD/2006-DC (ReReg. 2010) End 01
MD-50
31-03-2014
31-902-MD/2011-DC
MD-920
14-05-2014
Kendall Curity Latex Foley Catheter
(Indwelling Urinary Catheter)
31-333-MD/2007-DC
(Re-Reg. 2011)
MD-333
31-05-2014
1.
2.
Kit VECSE 27G Whitacre/
18G Weiss
Kit Perisafe 18G x 3/12”
Weiss
1.
27
123.
600010
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building No. 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri (E),
Mumbai-400093
124.
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building No. 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri (E),
Mumbai-400093
125.
M/s. KOB Medical
textiles Private Limited, 9.
Manirajanna Gardens, D.
No. 1996-C, Trichy Road,
Singanallur, Coimbatore641005
M/s. St. Jude medical
India private Limited, A
& B, 2nd Floor, “Brij
Tarang”, Greenlands,
Begumpet, Hyderabad500016
M/s. Bioaide technologies
Private Limited, 207,
Savitri Cinema Complex,
Greater kailash II, New
Delhi
126.
127.
M/s. Medtronic Sofamore
Denek inc, 1800 Pyramid
Place Memphis TN 38132,
USA having factory
premises at M/s.
Medtronic Sofamore
Danek, Deggendorf,
Werfstr 17, 94469,
Deggendorf, Germany
M/s. Medtronic Sofamore
Denek inc, 1800 Pyramid
Place Memphis TN 38132,
USA having factory
premises at M/s.
Medtronic Sofamore
Danek, Deggendorf,
Werfstr 17, 94469,
Deggendorf, Germany
M/s. Karl Otto Braun
GmbH & Co., KG,
Lauterstrasse 50, 67752,
Wolfstein, Germany
M/s. Light Lab Imaging
Inc, One technology Park
Drive, Westford, MA
01886, USA
M/s. Lohmann and
Rauscher International
GmbH & Co., Kg,
Westerwaldstrasse 4.
56579 Rengsdorf,
1.
2.
PEEK Prevail Cervical
Interbody Device
CLYDESDALE Spinal
System
Mastergraft Granules
1.
Kobra Cast-Thermoplastic
Cast Bandage
2. Rinkilastic CohesiveCohesive Elastic Bandage
3. Rapidelast Color-Cohesive
Elastic bandage
C7 Dragonfly Imaging Catheter
1.
2.
3.
Curapor (Sterile Island
Dressing)
VIiwazell (Sterile Dressing
Pad)
Metalline (Sterile Dressing
31-69A-MD/2006-DC
(Re-Reg. 2009) End 01
MD-69A
14-03-2014
31-69A-MD/2006-DC
(Re-Reg. 2009) End 02
MD-69A
14-03-2014
31-920-MD/2011-DC
MD-920
31-05-2014
31-896-MD/2010-DC
MD-896
31-05-2014
31-490-MD/2008-DC
(Re-Reg. 2011)
MD-490
30-06-2014
28
Germany
Pad)
Raucodrape Surgical Incise
Drape
Total 6 drugs
4.
128.
129.
130.
131.
132.
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, Dist-Thane,
Bhiwandi
M/s. DePuy medical
private Limited, Plot no.
4, Survey No. 277/4,
Demni Road, VillageDadra-Dadra & Nagar
haveli (U.T.)
M/s. Terumo
Corporation, Chennai
Branch, Alexander
Square, 34 & 35, 4th Floor,
Sardar Patel Road,
Guindy, Chennai-600032
M/s. Spinemed Systems,
LG-1, Pankaj Market,
Behind Natraj Vihar
Society, I.P. Extn.
Patparganj, Delhi-110092
M/s. Ethicon Sarl, Puits
Godet 20, 2000 Neuchatel,
Switzerland
M/s. Hester Diagnostics
Private Limited, Room
No. 9, 1st Floor, 66,
princess Street, Mumbai400002
M/s. Penumbra Inc, 1351,
Harbor Bay, Parkway,
Alameda, CA 94502, USA
M/s. DePuy
International Limited,
trading as M/s. DePuy
CMW, Cornford Road,
Blackpool, FY4 4QQ,
England UK
M/s. Vascutek limited, A
Terumo Company,
Newmains Avenue,
Inchinnan, Renfrewshire,
PA4 9RR, Scotland
M/s. Orthofix Inc, 3451,
Plano Parkway,
Lewisville, Tx 75056
31-845-MD/2010-DC
(End 01)
MD-845
30-04-2014
Total 7 drugs
31-915-MD/2011-DC
MD-915
31-05-2014
Total 6 drugs
31-880-MD/2010-Dc
MD-880
14-06-2014
31-976-MD/2011-DC
MD-976
31-05-2014
31-499-MD/2008-DC
(Re-Reg. 2011)
MD-499
30-09-2014
1.
2.
3.
Spinal Fixation System
Ascent TM POCT System
Firebird Spinal Fixation
System
4. 3 Deg Anterior Cervical Plate
System
5. Pillar Peek Spacer System
6. Construx Peek Partial VBR
System
Penumbra System consisting of:
1. Penumbra Reperfusion
Catheter
2. Penumbra Separator
3. Penumbra Aspiration Tubing
4. Neuron delivery Catheter
29
133.
134.
135.
M/s. Smith & nephew
Healthcare Private
Limited, C/o Shebros
Agencies, Minakshi
Industrial estate, Gala -1,
Building-1, Naikpada,
W.E. Highway, Vasai (E),
Maharashtra-410208
M/s. St. Jude medical
India private Limited, A
& B, 2nd Floor, “Brij
Tarang”, Greenlands,
Begumpet, Hyderabad500016
M/s. DePuy Medical
Private Limited, 64-66
Senapati Bapat Marg,
Mahim, Mumbai-400016
136.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
137.
M/s. Abbott Healthcare
Private Limited, 4,
Corporate Park, Sion
Trombay Road, Mumbai400071
M/s. Smith & Nephew
Medical Limited, 101
Hessle Road, Hull, HU3
2BN, UK
M/s. St. Jude Medical
System AB,
Palmbladsgatan 10, Box
6350 SE 75135 Uppsala,
Sweden
M/s. DePuy Spine, Inc,
325 Paramount Drive,
Raynham, Massachusetts
02767, USA having
factory premises at M/s.
DePuy Inc, 50 Scotland
Park Drive, Bridgewater,
Massachusetts 02324,
USA
M/s. Clearstream
Technologies Limited,
Moyne Upper,
Enniscorthy Co. Wexford,
Ireland
M/s. Abbott Laboratories,
Abbott Vascular Inc, 400
Saginaw Drive, redwood
City, California 94063,
USA
5. Neuron Select Catheter
Acticoat/Acticoat7
31-969 (FF-159)MD/2011-DC
MD-969
(FF-159)
30-04-2012
31-727-MD/2009-DC
MD-727
14-07-2014
Moss Miami Spinal System (NonSterile)
31-288-MD/2006-DC
(Re-Reg. 2010) End 01
MD-288
14-06-2013
Sleek PTW PTA balloon Catheter
(Sterile)
31-239-MD/2006-D (ReReg. 2009) (End 01)
MD-239
31-12-2012
31-867-MD/2010-DC
MD-867
30-06-2014
1.
2.
1.
2.
PressureWire Aeris
Including PressureWire
Receiver
PressureWire Certus
Prostar XL Percutaneous
Vascular Surgical System
and Accessories
Perclose ProGlide SutureMedicated Closure System
and Accessories
30
138.
M/s. Johnson and
Johnson Limited, J-1
Shree Arihant Complex,
Vill Kalher, ThaneBhiwandi Road, DistThane, Bhiwandi
139.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
M/s. Zimmer India
Private Limited, Plot No.
B & B1, vanijya Nikunj, 7th
Floor, Enkay Tower,
Udyog Vihar, Phase-V,
Gurgaon-122016
M/s. becton Dickinson
India Private Limited, No.
34 Assisi Nagar, West
Thottam, Madhavaram,.
Chennai-51
140.
141.
M/s. Johnson & Johnson
Wound Management, a
division of M/.s. Ethicon
Inc, Route 22 West
Somerville, new Jersy
08876-0151, USA having
factory premises at M/s.
Integra neuroscience PR
Inc, State Road 402,
Anasco, PR 00610, Puerto
Rico, USA
M/s. VNUS medical
technologies Inc, 5799
Fontanoso Way, San Jose
CA 95138, USA
Biopatch Antimicrobial Dressing
with Chlorhexidine Gluconate
31-815(B) (FF-325)MD/2008-DC (Re-Reg.
2010)
MD-815(B)
14-07-2014
Catheter (Closure Fast Closure RFS)
31-789-MD/2010-DC
MD-789
14-07-2014
M/s. Zimmer Inc, 1800
West centre Street,
Warwaw, Indiana 46580,
USA
Cable Ready Cable Grip System
31-170-MD/2006-DC
(Re-Reg. 2009) End 03
MD-170
31-07-2012
M/s. Becton Dickinson
Infusion Therapy AB,
Gasebacksvagen 36, PO
Box 631, 251 06
Helsinborg, Sweden
having factory premises
at M/s. becton Dickinson
Infusion Therapy Systems
Inc, SA de C.V. 579
Periferico Luis Donaldo
Colosio, Colonia Obrera
in Nogales Sonora 84048,
mexico
BD Connecta
31-911-MD/2011-DC
MD-911
30-06-2014
31
142.
143.
144.
145.
146.
147.
M/s. Biomet Orthopaedic
India Private Limited,
2301, Shanti Esate,
Ghansham Estate,
National Highway No. 8,
Aslali, Tal: Daskroi (NA)
M/s. Exactech India
Private Limited, No. 21,
‘F’ Block, 2nd Floor,
Annanagar east, Chennai600102
M/s. Biomet 3i, 4555
Riverside Drive, palm
beach Gardens, Florida
33410, USA
31-900-MD/2010-DC
MD-900
30-06-2014
Total Hip Replacement
System-cemented
2. Total Hip Replacement
System-Cementless
3. Total Knee Replacement
System
4. Exactech Equinoxe Shoulder
System
Pantera Lux Paclitaxel Releasing
PTCA Balloon Catheter
31-503-MD/2008-DC
(Re-Reg. 2011)
MD-503
31-07-2014
M/s. Biotronik medical
devices India Private
Limited, 101-106, Plot No.
14, LSC, Kalkaji, New
Delhi-110019
M/s. Cosmotec
Medicaments Private
Limited, No. 2, 1st Floor,
HR-8, Balaji Complex,
Sharma Market,
Pulpehladpur, New delhi110044
M/s. Baxter India private
Limited, 2nd Floor, Towe
C, Building 8, DLF Cyber
City, Phase-II, Gurgaon122002
M/s. Vascular Solutions
India private Limited,
Building No. H-142, 1st
Floor, Rajlaxmi
Commercial Complex,
M/s. Biotronik AG,
Ackerstasse 6, 8180
Bulach, Switzerland
31-461-MD/2006-DC
(Re-Reg. 2010) End 01
MD-461
30-04-2014
M/s. Mondeal Medical
System GmbH,
Gewerbering 7, 78570
Muhlheim an der Danau,
Germany
Orthopaedic Implants (Non-Sterile)
Mondeal Titanium Orthopaedic
Implants (Plates, Screws, Pins, Mesh)
31-814(A)-MD/2010-DC
MD-814 (A)
14-06-2014
M/s. baxter Healthcare
Croporation, 21026,
Alexander Court,
Hayward, CA 94545, USA
Floseal Special Applicator Tips
31-734(A)-MD/2009-DC
(Re-Reg. 2011) End 01
MD-374(A)
14-01-2014
31-231-MD/2006-DC
(Re-Reg. 2010) End 01
MD-231
14-06-2013
M/s. Exactech Inc, 2320,
2243, 2402 & 2411, NW
66th Court, Gainesville,
Florida 32653, USA
M/s. Clearstream
Technologies Moyne
Upper, Enniscorthy, Co.
Waxford, Ireland
Dental Implant System
1.
1.
2.
3.
4.
Nimbus Salvo PTCA
Catheters
EzeCTO PTCA Catheters
EzeCTO-RX PTCA Catheters
FlexeCTO PTCA Catheters
32
148.
149.
150.
151.
152.
Kalher, Thane-Bhiwandi
Road, Bhiwandi-421302
M/s. Zimmer India
Private Limited, Plot No.
B & B1, Vanijya Nikunj,
7th Floor, Enkay Tower,
Udyog Vihar, Phase-V,
Gurgaon-122016
M/s. Clairvoyance
Consulting, Flat No. 801,
8th Floor, Indra Prakash
Building, 21 Barakhamba
Road, Connaught Place,
New Delhi-110001
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, District-Thane,
Bhiwandi
M/s. DePuy Medical
private Limited, 64-66,
Senapati Bapat Marg,
Mahim, Mumbai-400016
M/s. Atlantic
Pharmaceuticals, 101,
Business Point 349,
Western Express
Highway, Andheri (E),
M/s. Zimmer GmbH,
Sulzer Allee 8, CH-8404
Winterthur, Switzerland
1.
2.
3.
Ceramic Femoral Head
Metal (CoCr) Femoral Head
Metasul Head
31-171-MD/2006-DC
(Re-reg. 2009)End 05
MD-171
31-07-2012
M/s. Invatec Technology
centre GmbH,
Hungerbuelstrasse 12a,
8500 Frauenfeld,
Switzerland
Maris Plus-Peripheral SelfExpanding Stent System
31-833-MD/2010-DC
(End 02)
MD-833
31-03-2014
M/s. Ethicon Inc, Route
22 West, Somerville, New
Jersy 08876-0151, USA
having factory premises
at M/s. Ethicon Inc, 5250
Greens Dairy Road,
Raleigh, North Carolina
27616, USA
M/s. DePuy Spine Inc,
325 Paramount Drive,
Raynham, Massachusetts
02767, USA having
factory premises at M/s.
DePuy Inc, 50 Scotland
Park Drive, Bridgewater,
Massachusetts 02324,
USA
M/s. Joline GmbH & Co.
KG Neue Rottenbunger
Str, 50-D-72379
Hechingen
Ethicon OMNEX Surgical Sealant
31-899-MD/2010-DC
MD-899
30-06-2014
Uniplate 2 Anterior Cervical
Plate System
Expedium Spine SystemPeek Rod
31-288-MD/2006-DC
(Re-Reg. 2010) End 02
MD-288
14-06-2013
Double Lumen ST Catheter
Kit
Double Lumen LT Catheter
Kit
31-243-MD/2006-DC
(Re-Reg. 2010)
MD-243
14-07-2014
1.
2.
1.
2.
33
153.
154.
Mumbai-400069
M/s. Anand
mediproducts Private
Limited, 16, Road No. 33,
Punjabi Bagh Extn, New
Delhi-110026
M/s. Globe Bio-Medical,
C/2 Juhu Apartments,
Near S.N.D.T. College,
Juhu, Mumbai-4000049
M/s. Degradable
Solutions AG,
Wagistrasse 23 CH-8952
Schieren, Switzerland
M/s. Alco-advanced
Lighweight construction
GmbH, Teplitzer str, 5-D,
14193, Berlin, Germany
155.
M/s. Amardeep
Enterprises, No. 5-6, 3rd
Floor, Nr. Income Tax
Building, Ashram Road,
Ahmedabad-380009
156.
M/s. St. Jude Medical
India Private Limited, A
& B, 2nd Floor, Brij Tarang,
Greenland, Begumpet,
Hyderabad-500016
M/s. metro Biosol Private
Limited, 26 Hauz khas
Vill, New Delhi-110016
M/s. Solco Bio-Medical
Co. Limited, 34-6,
Keumam-ri, Seotanmyeon Pyengtack,
Gyeonggi-do, 451-852,
The Republic of Korea
M/s. St. Jude medical
cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar 91342, USA
M/s. VEXIM SAS, 75, rue
Saint Jean, 31130, Balma,
France
M/s. India Medtronic
Private Limited, 1241,
Solitaire Corporate Park,
Building No. 12, 4th Floor,
Andheri-Ghatkopar Link
Road, Andheri (E),
Mumbai-400093
M/s. Medtronic Inc, 710
Medtronic Park Way, NE
Minneapolis, MN-=55432,
USA having factory
premises at M/s.
Medtronic Ireland
Markmore Business Park,
157.
158.
Easy Graft/Crystal
31-870-MD/2010-Dc
MD-870
31-07-2014
Alis CR L 605 Rapamycin
Eluting Coronary Stent
2. Alis 20 Coronary Stent
3. Alex-R Rapamycin Eluting
PTCA Catheter
4. Alex Coronary Dilation
Catheter
4CIS Solar Spine System (NonSterile)
31-04-MD/2006-DC (Rereg. 2009)
MD-04
30-06-2012
31-383-MD/2007-DC
(Re-Reg. 2011)
MD-383
31-07-2014
Total 7 drugs
31-300-MD/2007-DC
(Re-Reg. 2010) End 01
MD-300
14-09-2013
Spine Jack System
1. Preparation Kit
2. Expansion Kit
3. Cohesion Bone Cement
Valiant Thoracic Stent Graft with the
Captivia delivery System
31-924-MD/2011-DC
MD-924
31-07-2014
31-64-MD/2006-DC (ReReg. 2009) End 09
MD-64
31-07-2012
1.
34
159.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
160.
M/s. Apothecaries
Private Limited, 579,
devil, East of Sainik
Farms, New Delhi-110062
161.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
162.
M/s. fenwal India private
Limited, Khasra # 1220,
1st & 2nd Floor, Village
Ritahla, Delhi-110085
West Galway, Ireland
M/s. Johnson & Johnson
International, C/o
European Logistics centre
Lenneke Marelann 6, BE1932 St Stevens Woluwe,
Belgium having factory
premises at M/s. Johnson
& Johnson Medical
GmbH, Robert Koch
Srasse 1, D-22851
Norderstedt, germany
M/s. Hoya Corporation,
2-7-5 Naka-Ochiai,
Shinjuku-Ku, Tokyo 1618525, Japan having
factory premises at M/s.
Hoya Medical Singapore
Pte Limited, 455A, Jalan
Ahmad Ibrahim 639939,
Singapore
M/s. Biosense Webster
Inc, 3333 Diamod Canyon
Road, Diamod Bar, CA
91765, USA having
factory premises at M/s.
Biosense Webster Inc,
Circuito Interior Norte
#1820, Parquw Industrial
Salvacar, Juarez,
Chihuahua, Mexico 32599
M/s. Fenwal Inc, Three
Corporate Drive, lake
Zurich IIlinois 60047, USA
having factory premise at
Physiomesh
31-816(FF-319)MD/2008-DC (Re-Reg.
2011) End 01
MD-816
(FF-319)
14-02-2014
Hoya AF-1iMics1 NY-60
31-701-MD/2009-DC
(End 01)
MD-701
30-11-2012
Webster CS Catheter
31-119-MD/2006-DC
(re-reg. 2009) End 01
MD-119
31-05-2013
31-963-MD/2011-DC
MD-963
31-07-2014
1.
2.
3.
Amicus Apheresis Kit
Closed System Apheresis Kit
Open System Apheresis Kit
35
163.
164.
M/s. Johnson & Johnson
Limited, 30 Forjett Street,
Mumbai-400036
M/s. Cure Surgicals,
Shop No. 4, G.F. Green
Park Extn, New Delhi
165.
M/s. Covidien Healthcare
India Private Limited,
“Doshi Towers”, 6th Floor,
#156, Poonamallee High
Road, Kilpauk, Chennai600010
166.
M/s. Boston Scientific
International BV, 100A,
The Capital Court, Olof
Plame Marg, Munirka,
New Delhi-110067
M/s. Fenwal
International Inc, Camino
Real Industrial park, Road
# 122, San German,
Puerto Rico 00683, USA
M/s. Ethicon Inc, Route
22 West, Somerville, New
Jersy 08876-0151, USA
M/s. GS Medical Co.
Limited, 12-F, Kolon
Digital Twoer Aston, 50514, Gasan-dong,
Geumcheon-gu, seoul,
153-803, Korea having
factory premises at M/s.
GS Medical Co. Limited,
#636, Yeonje-ri, Gangoemyeon, Cheongwon-gun,
Chungbuk, Korea
M/s. Covidien IIc, 15
Hampshire Street,
Mansfield MA02048, USA
having factory premises
at M/s. Covidien,
Building 911-67,
Sabanetas Industrial park,
Ponce, Puerto Rico 00731,
USA
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
1. Prolene Soft Mesh
2. Gynecare Gynemesh PS
3. Vicryl Mesh
GSS Pedicle Screw System
31-906 (FF-132)MD/2011-DC (end 01)
FF-132
28-02-2012
31-945-MD/2011-DC
MD-945
31-07-2014
Surgipro II Monofilament
Polypropylene Suture
31-796-MD/2010-DC
(Re-Reg. 2011) End 01
MD-796
30-04-2014
31-857-MD/2010-DC
MD-857
31-07-2014
1.
2.
3.
4.
Apex Over-The-Wire PTCA
Dilatation catheter
Maverick2 Monorail PTCA
Dilatation Catheter
Express Vascular SD
Premounted Stent System
Gateway PTA Balloon
Catheter
36
167.
168.
169.
170.
171.
M/s. Surgimed, D-22
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,
Gurgaon-122016
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, District-Thane,
Bhiwandi
M/s. Zimmer India
Private Limited, Plot No.
B & B1, Vanijya Nikunj,
7th Floor, Enkay Tower,
Udyog Vihar, Phase-V,
Gurgaon-122016
M/s. Teleflex Medical
private Limited, Old No.
10, No. 19, 1st Floor,
Ground Floor, Harrington
Road, Chetpet, Chennai600031
55311-1566, USA
M/s. Vascular Solutions
Inc, 6464 Sycamore Court,
Minneapolis, Minnesota
55369, USA
M/s. Zimmer Spine Inc,
5301 Riata Park Court,
Building F, Austin, Tx
78727, USA
M/s. Acclarent Inc, 1525B O’Brien Drive, Menlo
Park, CA 94025
M/s. Zimmer GmbH,
Sulzer Allee 8, CH 8404,
Winterthur, Switzerland
M/s. Teleflex Medical,
IDA Business and
technology Park, Athlone,
Ireland having factory
premises at M/s. Teleflex
Medicals Sdn. Bhd. Lot no
PT2577, Jalan Perusahaan
4, Kamunting Industrial
Estate, 34600 Kamunting
Perak, Malaysia Germany
GuideLiner Catheter
31-202-MD/2006-DC
(Re-reg. 2010) End 01
MD-202
14-09-2013
Sequoia Pedical e Screw System
31-864-MD/2010-DC
MD-864
31-07-2014
Relieva Solo Pro Sinus
Balloon Catheter (with or
without stylet)
2. Relieva Flex Sinus Guide
Catheter
3. Relieva Vortex Sinus
Catheter
4. Inspira Air Balloon Dilation
System
NCB Polyaxial Locking Plate System
31-890-MD/2010-DC
MD-890
31-07-2014
31-171-MD/2006-DC
(Re-Reg. 2009) End 02
MD-171
31-07-2012
Tracheal Tube (Teleflex ISIS Tracheal
Tubes-Catalogue#112662)
31-851-MD/2010-DC
MD-851
31-07-2014
1.
37
172.
M/s. Johnson & Johnson
Limited, J-1, Shree
Arihant Complex, Vill.
Kalher, Thane-Bhiwandi
Road, District-Thane,
Bhiwandi
173.
M/s. Mn Solutions, Shop
No. 26-27, 2nd Floor, Prop.
No. WZ-26, Nangli Jalib
Village, Janak Puri, New
Delhi-110058
174.
M/s. B L Lifesciences
Private Limited, a-245,
Okhla Industrial Area,
Phase-I, New Delhi110020
M/s. Mentor, 3041
Skyway Circle North,
Irving, Texas 75038, USA
having factory premises
at M/s. Genzyme
Biosurgery, 1125 Pleasant
View, Terrace, Ridgefield,
New Jersy 07657, USA
M/s. Arthrocare
Corporation, 680
Vagueros Avenue,
Sunnyvale, CA 94085,
USA having factory
premises at M/s.
Arthrocare Costa Rica
502, Global Parkway,
Global Park, la Aurora
Heredia, Costa Rica
M/s. Kinamed
Incorporated, 820 Flynn
Road, Camarillo,
California 93012-8701,
USA
Prevelle Silk Dermal Filler
1.
2.
Opus Anchor SuturesRotator Cuff Repairs
Opus Anchor Sutures for
Labral Repair
NeuroPro the complete
Neurosurgical Rigid Fixation System
(Non-Sterile)
31-879-MD/2010-DC
MD-879
31-07-2014
31-774-MD/2010-DC
MD-774
31-07-2014
31-237-MD/2010-DC
(Re-Reg. 2010)
MD-237
31-07-2014
38