Year 2012 - Central Drugs Standard Control Organization

advertisement
Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical
Devices
(Jan. 2012 to Dec. 2012)
#
1.
2.
3.
4.
Name of the
Manufacturer
M/s. Sony Surgical Private
Limited, Plot No. 68, New
GIDC, B/h Maxwell
Industries, Umergaon, DisttValsad
M/s. Bhartiya Surgicals,
Pahelwan Bidiwala
Compound, Dafnala Road,
Shahibag, Ahmedbabad380004
M/s. SM Health Care
Products Private Limited, B113, Sec-2, DSIIDC, Bawana
Industrial Area, Delhi-110039
M/s. Surgimedik Healthcare,
Surgimedik House, Plot No #
223, Surat Special Economic
Zone, Sachin, Surat-394230
Product Licenced by CLAA
1. Dynamic Compression Hole + 44
1.
2.
3.
4.
5.
6.
7.
1.
2.
3.
4.
1.
2.
3.
4.
5.
Sterile Disposable Single Use “Scalp Vain Set”
Catheter Sterile Disposable Single Use “Suction catheter”
Catheter Sterile Disposable Single Use “Infant Feeding Tube”
Catheter Sterile Disposable Single Use “Ryle’s Tube
Catheter Sterile Disposable Single Use “Urethral catheter”
Catheter Sterile Disposable Single Use “Gibbon’s Catheter”
Sterile Disposable Single Use “Infant Mucous Extractor”
Catheter & Stent
Needles
Guide Wire
Blood Tubing Set
Surgimedik Urological Catheter
Surgimedik Gynecological Catheters
Surgimedik Nehprological Catheter
Surgimedik Gastroenterological Catheters
Surgimedik Radiological Catheters
Manufacturing Licence
No. & Validity
Mfg Lic in Form 28 vide no.
G/28/1394 (23/11/2011 to
22/11/2016)
Mfg Lic in Form 28 vide no.
G/28/1389 (29/09/2011 to
28/09/2016)
NIL
Mfg Lic in Form 28 vide no.
G/28/1384 (17/08/2011 to
16/08/2016)
5.
M/s. Global Ophthalmic
Private Limited, Plot No. 3,
First Main Road, Sri Ram
Sanaji Nagar, Chennai
6.
M/s. Nano Therapeutics
Private Limited, D-54/2
Hoziwala Industrial Estate,
Sachin, Surat, Gujarat-394230
M/s. Envision Scientific
Private Limited, 1-3 Silver
Palm, 11 Nr. Sneh Milan
Garden, Nanhura, Surat,
Gujarat
M/s. Yogeshwar Implant
Private Limited, D-2 Kothari
Compound-5 Air, Thikujini
Wadi Road, Manpada, Thane
(W), Maharashtra
M/s. G. Surgiwear Limited,
Rasoolpur, Jahanganj,
Shahjahanpur-242001, UP
7.
8.
9.
1.
2.
3.
4.
Single Piece PMMA Intraocular Lens
Mfg Lic in Form 28 vide no.
Single Piece PMMA Aspheric Square EDGE Intraocular Lens
TN00003111
Hydrophilic Acrylic Foldable Intraocular Lens
Hydrophilic Acrylic Foldable Aspheric Square EDGE Intraocular
Lens
5. Natural Yellow Hydrophilic Acrylic Foldable Aspheric Square
EDGE Intraocular Lens
6. Hydrophilic Acrylic Foldable Aspheric Square EDGE Intraocular
Lens
Natural Yellow Hydrophobic Acrylic Foldable Aspheric Square EDGE
Intraocular Lens
Cardiac Stent
Mfg Lic in Form 28 vide no.
G/28/1395 (12/12/2011 to
11/12/2016)
Drug Eluting Balloon Catheter
Mfg Lic in Form 28 vide no.
G/28/1396 (19/12/2011 to
18/12/2016)
Non Sterile Orthopaedic Implant
Mfg Lic in Form 28 vide no.
KD-504 (03/02/2012 to
02/02/2017)
1. Catheters
2. Internal Prosthetic Replacement
3. Bone Cement
Mfg Lic No. NIL and Validity
NIL
10.
M/s. George Philips Medical
Engineering Private Limited,
B-43, MIDC, Anand Nagar,
Additional Ambarnath, DisttThane-421506, Maharashtra
11.
M/s. Dr. Surgical, J-1024,
I.I.D. Khushkhera Industrial
Area, Bhiwandi, Distt-Alwar,
Rajasthan
12.
M/s. Poly Medicure Limited,
Plot no. 115, HSIDC Sector59, Ballabgarh, DisttFaridabad, Haryana-121004
1. Thoracic Drainage Catheter in Plain, Angled or with Trocar in 16,
20, 24, 28, 32 and 36 Fr Sizes
2. Central Venous Catheter Kits of Single lumen, Double Lumen,
Triple Lumen or Quadruple Lumen in Adult, Pediatric or
Neonatal sizes
3. Central Venous Pressure Monitoring Kits with Rigid tube type or
with Rigid Scale with Tube types
4. Dialysis catheter kits with Straight or Curved catheters of Adult
and Pediatrics sizes
5. Nasal cannula and Catheter in Adult, Pediatric and Neonatal
sizes
6. Femoral Catheters-Port Length: 20-25 mm: Catheter Body: large,
160-170 mm; medium, 140-150 mm; small, 120-130 mm Length
and Femoral Catheter Kits
7. Angiokits, PTCA kits variants
8. Endotracheal Tubes-Plain 2, 2.5, 3, 3.5, 4, 4.5, 5 sizes and Cuffed 4,
4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 sizes in regular or in
Armored (reinforced) types
9. Epidural Kits of 16Fr and 18Fr sizes
10. Guide wires- 45cm, 70cm, 150cm, 260cm, coated/uncoated, with
straight/J tip/S tip types
1. Guide Wire
2. Chest Drainage Catheter
3. Hemodialysis Catheter
4. Diasnostic Catheter
5. Cath Labs Kit
6. Introducer Sheath
1. IV Cannula with Injection port and wings
2. IV Cannula with wings without injection port
3. IV Cannula without injection port and wings
4. IV cannula with injection port and wings
5. IV Cannula with wings without injection port
6. IV Cannula without injection port and wings
7. IV Cannula with injection port, snapfit cap & suturable wings
8. IV Cannula with wings & without injection port
9. IV Cannula without injection port and wings
Mfg Lic in Form 28 vide no.
KD-505 (06/02/2012 to
05/02/2017)
Mfg Lic No. NIL and
Validity NIL
Mfg Lic in Form 28 vide no.
627-B (H) (06/03/2011 to
05/03/2016)
13.
M/s. Care Group India Block
No. 310/E, Village-Dabhasa
Tal-Padra, Dist-Vadodara
1. Foldable Hydrophilic Acrylic Intraocular Lens (Sterile)
2. Yellow PMMA Intraocular Lens (Sterile)
3. PMMA Intraocular Lens (Sterile)
Mfg Lic in Form 28 vide no.
G/1333 (03/05/2010 to
02/05/2015)
14.
M/s. Bio-Med Healthcare
products Private limited, 30
DLF Industrial Estate Estate01, Faridabad-Haryana
M/s. Spectra Vision Plot No.
14, Shed No. 44, 45 & 46, B/H
ST Work Shop, Near Maruti
Service Centre, GIDC Chitra
Distt-Bhavnagar-364004
M/s. MIV Therapeutics India
Private Limited, 136B, Surat
Special Economic Zone,
Diamond Park, GIDC, Sachin,
Surat, Gujarat
1. IV Cannula with small wings & without port Size
2. IV Cannula with Suturabel wings & Snap fit port size
Mfg Lic in Form 28 vide no.
651-B (H) (valid up to
24/07/2012)
1. Foldable Hydrophilic Acrylic Intraocular Lens (Sterile)
2. Foldable Hydrophilic Yellow Acrylic Intraocular Lens (Sterile)
Mfg Lic in Form 28 vide no.
G/1320 (valid up to
24/11/2014)
1. genXSync Coronary Stent and Stent System
2. genXSync Plus Coronary stent system
Mfg Lic in Form 28 vide no.
G/28/1261 (valid up to
05/10/2012)
M/s. Relisys Medical device
Lilmited, Sy. No. 312,
Pocharam Road, Mangalpally
Village, Ibrahimpatnam
Mandal, ranga Reddy Distt501510
M/s. Yogeshwar Implants
India Private limited, D-2
Kothari Compound, 5 AcresThikujni Wadi Road,
Manpada Thane (W)
1.
2.
3.
4.
Mfg Lic in Form 28 vide no.
19/RR/AP/2006/MD/R
(29/11/2011 to 28/11/2016)
15.
16.
17.
18.
Cardiac Stents, (ETO Sterilized) Legend
Cardiac Stents, (ETO Sterilised) Legend MINI
Cardiac Stents (ETO Sterilised) Legend V
Cardiac Stents (ETO Sterilised) Cobal + C
1. Bone Screws
2. Bone Plates
3. IM Nails
4. Wires & Pins
5. Hemi Endo prosthesis
6. IM Nail (Tibia nail)
7. IM Nail (Femur Nail)
8. IM Nail (Humerus Nail)
9. IM Nail (Femur Nails)
10. Bone Screws
11. Bone Plates
12. IM Femur Nail
13. IM Nails
Mfg Lic in Form 28 vide no.
KD-504 (03/02/2012 to
02/02/2017)
19.
20.
M/s. George Philips Medical
Engineering Private Limited,
B-43, MIDC, Anand Nagar,
Additional Ambarnath, DisttThena-421506
M/s. Medi Plus India
Limited, 1261, 1262, MIE,
Bhadurgarh, Haryana-124507
21.
M/s. Hindustan Syringes &
Medical devices Limited, 174,
Sec-25, Ballabhgarh,
Faridabad-121004
22.
M/s. Bio-Med Healthcare
Product Private Limited, Plot
No. 62-65, Sector-6A,
SIDCUL, Ranipur, Haridwar249403
M/s. Lars Medicare Private
Limited, Kila No. 16 & 17,
Village Sultanpur, G.T. Road,
Bahalgarh Chowk, DisttSonepat-131021
23.
1.
2.
3.
4.
5.
1.
2.
3.
Disposable Perfusion sets
Disposable Perfusion sets/IV Cannula
Disposable Hypodermic Needle
IV Cannula
Catheters
3-way stop cock
Extension Tube
3-way stop cock with Extension tube
Mfg Lic in Form 28 vide no.
KD-505 (valid up to
05/02/2017)
Mfg Lic in Form 28 vide no.
646 B (H) (valid up to
31/05/2012)
1. Cathy
2. Kitkath
3. Kitkat+
4. Cathula
5. Dispocann
6. Select
7. Scalpvan
8. Select
9. Select Prevent
10. Vaku-8+
11. Unolok
12. Unolok+
13. Vaku-8
IV Cannula
Mfg Lic in Form 28 vide no.
636-B (H) (30-08-2011 to
29/08/2016)
VYTAP
Mfg Lic in Form 28 vide no.
660-B-H (valid up to
03/02/2013)
Mfg Lic in Form 28 vide no.
123/UA/SC/P-2007 (valid up
to 01/11/2012)
24.
M/s. Polymer technologies
International (EOU), Block
No. 310/C, Village-Dabhasa,
Tal. Padra Dist-Vadodara391440
25.
M/s. Nirma Limited, Survey
No. 358, 364, 359, 392 to 396,
482, 483, 901, 907 at & Pose
Sachana, tal. Viramgam,
Distt-Ahmedabad-382150,
Gujarat
M/s. Global Medikit Limited,
Khasra No. 323 (MI), Central
Hope Town, Camp Road,
Selaqui dehradun,
Uttrakahand
26.
27.
28.
M/s. Poly Medicure Limited,
Plot No. 115-116, HSIDC,
Sector-59, Ballabgarh, DisttFaridabad-121004
M/s. Veritas Bioventions
Private Limited, Plot No.
5305, Phase-IV, GIDC, Vapi396195
1.
2.
3.
4.
5.
6.
7.
8.
1.
2.
3.
4.
5.
PMMA Intraocular Lens (Sterile)
Yellow PMMA Intraocular Lens (Sterile)
Foldable Hydrophilic Acrylic Intraocular lens (Sterile)
Foldable Hydrophilic Acrylic Intraocular lens (Sterile)
Foldable Hydrophilic Yellow Acrylic Intraocular Lens (Sterile)
Foldable Hydrophilic Acrylic Intraocular Lens (Sterile)
Foldable Hydrophobic Intraocular Lens (Sterile)
Foldable Hydrophobic Yellow Intraocular Lens (Sterile)
Scalp Vein Infusion Set (Needle size 20G)
Scalp Vein Infusion Set (Needle size 21G)
Scalp Vein Infusion Set (Needle size 22G)
Scalp Vein Infusion Set (Needle size 23G)
Scalp Vein Infusion Set (Needle size 24G)
Mfg Lic in Form 28 vide no.
G/1321 (18/12/2009 to
17/12/2014)
Mfg Lic in Form 28 vide no.
G/28/1409 (valid up to
13/03/2017)
1. Central Venous Catheter
2. Central Venous Catheter Single Lumen
3. Central Venous Catheter Double Lumen
4. Central Venous Catheter Triple Lumen
5. Suction Catheter
6. Nelaton Catheter
7. Thoracic Catheter
8. Rectal Catheter
Introducer Cannula + 167
Mfg Lic in Form 28 vide no.
18/UA/SC/P-2009 (valid up
to 23/03/2014)
Elimin8-R
Mfg Lic in Form 28 vide no.
G/28/1379 (valid up to
21/07/2016)
Mfg Lic in Form 28 vide no.
627-B (H) (valid up to
05/03/2016)
29.
M/s. SQL Surgical (India)
Private Limited, Surampalli,
Ganavaram (M), Krishan
Distt-AP
30.
M/s. Translumina
Therapeutics LLP, Plot No. 9,
Pharmacity, Selaqui,
Dehradun-248197
M/s. Unique ortho Systems
private Limited, 648, GIDC
Waghodia, Distt-Vadodara
31.
32.
33.
34.
35.
36.
M/s. Poly Medicure Limited,
Plot No. 104-105, Sector-59,
HSIDC Industrial Area,
Ballabgarh, Faridabad-121004
M/s. Siora Surgicals Private
Limited, Plot No. 1792,
HSIDC Industrial Estate, rai
Sonepat, Haryana
M/s. Multi Medics, Plot No.
28, HPSIDC Phase-III, Baddi,
Distt-Solan-173005
M/s. iLife Medical Devices
Private Limited, #86, Sector56, Phase-IV, I.E. Kundli
Sonepat-131028
M/s. Poly Medicure Limited,
Plot No. 115-116, HSIDC,
Sector-59, Ballabgarh, DisttFaridabad-121004
1. Bone Plates
2. Bone Screws
3. Bone Nails
4. Prosthesis
5. Wires-Pins
6. Spine Implants
7. Locking Plates
8. Maxellofacial Implants
Sirolimus Drugs Eluting CoCr Coronary Stent System
Mfg Lic in Form 28 vide no.
37/KR/AP/2009/S/G (valid
up to 14/10/2014)
External Fixetor
External Fixetor Screw
Mfg Lic in Form 28 vide no.
G/28/1419 (29/05/2012 to
28/05/2017)
1. Polyvac Set Close wound suction unit
2. Polymed Novovac Set Close wound suction unit
3. Polymed Neovac set close wound suction unit
1. Siora Orthopaedic Bone Screws Non-Sterile
2. Siora Orthopaedic Bone Plates Non-Sterile
3. Siora Orthopaedic Bone Nails, Wires & Pins Non-Sterile
4. Siora Orthopaedic Hip Prosthesis Non-Sterile
E-Magic Plus
Mfg Lic in Form 28 vide no.
6/UA/SC/P-2011 (valid up
to)
Mfg Lic in Form 28 vide no.
644-B-H (24/05/2007 to
23/05/2012)
Mfg Lic in Form 28 vide no.
MB/10/836 (valid up to
21/01/2016)
Neotec
Mfg Lic in Form 28 vide no.
673-B-H (valid up to
12/08/2014)
IV Cannula & Catheters
Mfg Lic in Form 28 vide no.
627-B-H (valid up to
05/03/2016)
37.
38.
39.
40.
41.
42.
M/s. Newtech Medical
devices, B-198, 2nd Floor,
Okhla Industrial Area, PhaseI, New delhi-110020
M/s. Bio Med Healthcare
Products Private Limited, 30
DLF Industrial Estate-1,
Faridabad
M/s. Vitromed Healthcare,
A-27, Industrial Estate, 22
Godman Jaipur-302006
M/s. Hollister India Private
Limited, Plot No. #27, Sector5, Phase-II, HSIDC Growth
Center, Bawal, Distt-Rewari123501
M/s. Devon Innovations
Private Limited, Plot No. 27A, Near State Bank of India,
Electronic City, Phase-I,
Hosur Road, Bangalore560100
M/s. Universal Ortho
Systems, 926/2, 927/1, GIDC
Waghodia, Distt-Vadodara391760
1. Medcomp Dialysis Catheter
2. Medcomp Dialysis Catheter Kit
3. Introducer Sheath Catheter
4. Dilation Catheter
IV Cannula with/without wings & Injectable Port
Mfg Lic in Form 28 vide no. S
(0007)11/MD (valid up to
09/08/2016)
1. Endotracheal Tubes
2. Closed wound drainage set
3. Trachestomy tube with & without cuff
4. TUR Set
5. Levin’s Tube
6. Ryle’s Tube
7. Infant Feeding Tube
8. Stomach Tube
9. Foley Balloon Catheter
10. Redon Drainage Tube
Catheter (Sterile) and Catheters (non Sterile)
Mfg Lic in Form 28 vide no.
Raj-2346 (valid up to
07/02/2017)
Mfg Lic in Form 28 vide no.
651-B-H (valid up to)
Mfg Lic in Form 28 vide no.
676-B-H (valid up to)
1. Orthopaedic Implants
2. Catheters
Mfg Lic in Form 28 vide no.
KTK/28/395/2009 (valid up
to 15/06/2016)
1.
2.
3.
4.
5.
6.
Mfg Lic in Form 28 vide no.
G/28/1414 (19/04/2012 to
18/04/2017)
Bone Screws
Bone Plates
Nails
Pins & Wires
Joint Replacement Prosthesis
Spinal Implants
43.
M/s. Devparv Surgico,
D/1/C/ Diamond Park,
GIDCV, naroda Ahmedabad382330
44.
M/s. Poly Medicure Limited,
Plot No. 104-105, Sector-59,
HSIDC Industrial Area,
Ballabgarh, Faridabad-121004
M/s. Peekay mediequip
Limited, no. 131, Sengipatti,
Village, Thanjavur Trichy
Road, Thirumalasamudram
Thanjavur-613402
45.
1. Catheter Sterile Disposable single use Ryle’s tube
2. Catheter sterile disposable single use Levin’s tube size
3. Catheter Sterile disposable single use infact feeding tube
4. Catheter sterile disposable single use infant Mucus extractor
5. Sterile disposable single use Scalp Vein Set
6. Catheter Sterile diposable single use suction catheter
7. Catheter sterile disposable single use Nelation catheter
8. Catheter sterile disposable single use nasal oxygen catheter
9. Catheter sterile disposable single use rectal catheter
10. Catheter sterile disposable single use Urethral catheter
11. Catheter sterile disposable single use umbilical catheter
12. Catheter sterile disposable single use balloon catheter
13. Catheter sterile disposable single use thoracic catheter with trocar
14. Catheter sterile disposable single use Gibbon’s catheter
15. Sterile disposable IV Cannula
IV Cannula, Scalp Vein Set, different types of catheter
Mfg Lic in Form 28 vide no.
G/28/1402 (20/01/2012 to
19/01/2017)
IV Cannula
Mfg Lic in Form 28 vide no.
TN 00003181 (valid up to)
Mfg Lic in Form 28 vide no.
644-B-H (24/05/2012 to
23/05/2017)
46.
M/s. ETU Ortho Surgical
Parts, Plot No. D-105/B,
Lodhika GIDC, Metoda,
Distt-Rajkot-360021
47.
M/s. Multi Medics Plot No.
28, HPSIDC Phase-III, baddi
Distt-Solan-173205
48.
M/s. Lars Medicare Pvt. Ltd.,
Kila No. 16 & 17, Village
Sultanpur, G.T. Road,
Bahalgarh Chowk, Sonepat –
131021, Haryana
M/s. Relisys Medical Device
Ltd., Sy. No. 312, Pocharam
Road, Mangalpaly Village,
Ibrahimpatnam Mandal,
Ranga Reddy, Distt. – 501510,
Andhra Pradesh
49.
1. Cortical Screws
2. Malleolar Screws
3. DHS/DCS Screws
4. Interlocking Bolts
5. Cancellous & Cannulated Screws
6. Mono & Poly Xial Screws
7. Herbal Screws
8. Micro Plates
9. Reconscruction Plate
10. D.C. Plate
11. Tubular Plate
12. Later & Distal Tibeal: Femeral Plate (Left & Right)
13. Cobra Head Plates
14. DHS Plate
15. K-Wires & K-Nails
16. Interlocking Tibial & Feomeral Nails
17. Supera Condylar Plate (Left & Right)
18. Heumerous Nail
19. Elastic Nail
1. Tapper-S
2. Stream-S
3. Tapper-Cr
4. Stream-Cr
5. Tapper
6. Stream
Can-Care
Sirolimus Eluting Coronary Stent System
Mfg Lic in Form 28 vide no.
G/28/1413 (11/04/2012 to
10/04/2017)
Mfg Lic in Form 28 vide no.
MB/10/836 (valid up to
21/01/2016)
Mfg Lic in Form 28 vide no.
660-B-H (valid up to
03/02/2013)
Mfg Lic in Form 28 vide no.
19/RR/AP/2006/MD/R
(valid up to 28/11/2016)
50.
M/s. Polymer Technologies
Interantional (EOU), Block
No. 310/C, Village-Dabhasa,
Tal. Padra, Dist. Vadodara 391440
51.
M/s. Meril Life Sciences Pvt.
Ltd., Survey No. 135/2a,
Near GM Bilakhia Stadium,
Muktanand MArg, Challa,
Vapi-396195
M./s. Aurolab, No. 1,
Sivagangai Main Road,
Veerapanjan, Madurai 625020
M/s. Medi Plus India Ltd.,
1261, 1262 MIE, Bhadurgar
Haryana - 124507
52.
53.
54.
55.
56.
M/s. Harsoria Health Care
Pvt. Ltd., Lpot No. 110-111,
Udyog Vihar, Phase –IV,
Gurgaoon, Haryana
M/s. Poly Medicure Ltd, Plot
No. 115, HSIDC, Sector-59,
Ballabgarh, Distt. Faridabad,
Haryana - 121004
M/s. Nipro India
Corporation Pvt. Ltd., E-1,
MIDC, Kesurdi, Tal.
Khandala, Distt. Satara
1. PMMA Intraocular Lens
2. Yellow PMMA Intraocular Lens
3. Foldable Hydrophilic Acrylic Intraocular Lens
4. Foldable Hydrophilic Acrylic Aspheric Intraocular Lens
5.. Foldable Hydrophilic Yellow Acrylic Aspheric Intraocular Lens
6. Foldable Hydrophilic Intraocular Lens
7. Foldable Hydrophilic Yellow Intraocular Lens
Xpedient™ (Sterile)
Mfg Lic in Form 28 vide no.
G/1321 (valid up to
17/12/2014)
I-Vision Intra Ocular Len
Mfg Lic in Form 28 vide no.
TN00002501 (valid up to
19/07/2012)
Mfg Lic in Form 28 vide no.
G/28/1273 (valid up to
19/06/2013)
1. Cannula (For Export & Domestic ) - Cureflon
Mfg Lic in Form 28 vide no.
2. Safety I.V. Cannula (For Export & Domestic ) – Plusflon Safe, 646-B (H)
Pluscan Alpha Safe, Pluscan Safe, Plusvein Safe, Plusneo Safe
1. Metaflon/ Sterile Disposable IV Cannula with Cathter for
single use 2. JCM Med SV Concept/ Sterile Disposable IV Cannula with
Cathter for single use
1. Polyvac Set / Close wound suction unit
2. Polymed Novovac Set/ Close wound suction unit
3. Polymed Neovac Set/ Close wound suction unit
Mfg Lic in Form 28 vide no.
637-B (H) (valid up to
18/09/2016)
Mfg Lic in Form 28 vide no.
51/UA/SC/P-2009 (valid up
to 10/06/2014)
Nipro (Wing Cath)/ Steeile I.V. Cnnula (IVC) with wing & with Mfg Lic in Form 28 vide no.
port
PD/128 (valid up to
02/07/2017)
57.
M/s. Lakshmi Narayan Life
Care Pvt Ltd., # 477 D, Devi
Industrial House, Peenya 4th
Phase, Peenya Industrial
Area, Peenya, Bangalore 560058
58.
M/s. Sahajanand Laser
Technology Ltd., A-8, GIDC
Electronic Estate, Sector 25,
Gandhinagar – 382016,
Gujarat
LN- Sterile Disposable single with use Karman Cannulae without Mfg Lic in Form 28 vide no.
Adaptor
KTK/28/400/2011
Sterile Dsiposable single use Karman Cannulae with Adaptor
Sterile Disposable single use Suction Catheter without Thumb
Control
Sterile Disposable single use Suction Catheter with Thumb Control
Sterile Disposable Single use Rectal Catheter
Sterile Disposable Single use Thoracic Catheter with Trocar
Sterile Disposable Single use Thoracic Catheter without Trocar
Sterile Disposable Single use Foley Balloon Catheter 2way
Sterile Disposable Single use Foley Balloon Catheter 3way
Sterile Disposable Single use Infant Mucus Extractor
Sterile Disposable Single use Nelaton Catheter
Sterile Disposable Single use Infant Feeding Tube Catheter
Sterile Disposable Single use Endotracheal Tube Catheter
Sterile Disposable Single use Endotracheal Tube Catheter without
Cuff
Sterile Disposable Single use LN Endotracheal Tube Catheter
(Reinforced) Cuffed
Sterile Disposable Single use LN Endotracheal Tube Catheter
(Reinforced) Un-Cuffed
Sterile Disposable Single use Laryngeal Mask Airway Catheter
PTCA Balloon Catheter
Mfg Lic in Form 28 vide no.
G/28/1314
59.
M/s. Nano Therapeutics Pvt.
Ltd., D-54/2, Hojiwala,
Industrial Estsate, Sachin,
Surat - 394230
60.
M/s. Vertias Bioventions
Pvt. Ltd., Plot No. 5305,
Phase-IV, G.I.D.C., Vapi396195
61.
M/s. Polymer technologies
International (EOU), Block
No. 310/C, Village-Dabhasa,
Tal. Padra Dist-Vadodara391440
M/s. Sahajnanad Medical
Technologies Pvt. Ltd., Plot
No. 33, 34, 35, 52, 53 & 54,
Surat Special Economic Zone,
Sachin – 394230 Dsit. Surat
Gujarat
M/s. Aurolab, No. 1,
Sivagangai Main Road,
Veerapanjan, Madurai 625020
M/s. Lars Medicare Private
Limited, Kila No. 16 & 17,
Village Sultanpur, G.T. Road,
Bahalgarh Chowk, DisttSonepat-131021, Haryana
62.
63.
64.
1. Periflex Balloon Expandable Peripheral Staent System/ Balloon
Expandable Cobalt Chromium Peripheral Stent System
2. 2. Curatis Balloon Expandable Renal & Biliiary Stent System/
Balloon Expandable Cobalt Chromium Renal & Biliary Stent
System
3. Curex Paclitaxel Drug Eluting Dilataion Balloon Catheter (PTCA
& PTA)/ Paclitaxel Drug Eluting Dilatation Balloon Catheter
(PTCA & PTA)
1. SiNew
2. FluenCE
3. Freenix
4. FlexiCore
5. Elimin 8-R
6. Forel
7. Fleam
8. Fistula
9. Fictile
1. Foldabale Hydrophlic Intraocular Lens (Sterile)
2. Foldable Hydrophilic Yellow Intraocular Lens (Sterile)
Mfg Lic in Form 28 vide no.
G/28/1395 (valid up to
11/12/2016)
1. Coronary Drug Elutimg Stent System (Sterile) SupralimusCore®
2. Coronary Bare Metal Stent System - Coronnium® , Indocore®
3. ADMETAL™ - SupraFlex®
4. Flexilimus™
5. Protolimus™
Poly Hydroxy Ethyl Methacrylate
Mfg Lic in Form 28 vide no.
G/1385 (valid up to
28/08/2016)
I.V. Cannula
Mfg Lic in Form 28 vide no.
660-B (H) (valid up to
03/02/2013)
Mfg Lic in Form 28 vide no.
G/28/1379 (valid up to
21/07/2016)
Mfg Lic in Form 28 vide no.
G/1321 (valid up to
17/12/2014)
Mfg Lic in Form 28 vide no.
TN00002501 (valid up to
10/08/2014)
65.
66.
67.
68.
M/s. Kaushik Orthopaedic
Pvt. Ltd., Plot No. 1540,
HSIDC, Industrial Estate, Rai,
Sonepat (Haryana)
M/s. Mediplus (India) Ltd.,
1261-1262, MIE Part-B,
Bahadurgarh, Dist. Jhajjar
(Haryana) - 124507
M/s. Ace Osteomedica, Plot
No. 1999, MIE Part-B,
Bahadurgarh District Jhajjar
(Haryana)
M/s. B.L. Life Science Pvt.
Ltd., Sector-31, Ecotech-31,
Greater Noida, Gautam Budh
Nagar (UP)
1. Bone Screws & Washer
2. Bone Plates
Nil
I.V. Cannula
Mfg Lic in Form 28 vide no.
646-B (H) (valid up to
31/05/2017)
1. Non-Sterile Bone Screws - Screw (AO Type), Screws (ACE Type),
Modular Hand Implant
2.Non-Sterile Bone Plates – Anatomical Bone Plates, Locking
Plates, Modular Hand Implants
3.Non-Sterile Bone Nails
4. Non-Sterile Wires, Pins & Staples
5. Non-Sterile Spinal Implants
6. Non-Sterile MAXILLOFACIAL Implants – Screw (AO Type),
Screws (ACE Type), Maxillofacial Implants
7. Non-Sterile Hip Prothesis
Catheter1.Thoractic Drainage Catheter/ SurgX
2. Hemodialysis Catheter/ DiaX
3. Central Venous Catheter/ VenX
4.Angiographic Catheter/ AngiX
5. Angio Kit
6.PTCA Kit/ AngiX
7. Cath Lab Kit/ AngiX
8. Accessories of Angio Kit/ AngiX
9. Introducer Needle/ AngiX
10.Guidewire/ AngiX
11.Introducer Sheath/ AngiX
Arterial Venous Tubing
1.Hemodialysis Tubing Set Blood Tubing Set / DiaX
2.Arterial Venous Tubing/ DiaX
Nil
Mfg Lic in Form 28 vide no.
04/SC/P
69.
M/s. Poly Medicure Limited,
Plot no. 115, HSIDC Sector59, Ballabgarh, DisttFaridabad, Haryana-121004
70.
M/s. Envision Scientific Pvt.
Ltd., Plot No. 108,
Ichchhapore GIDC, Industrial
Estate Bhatpore, SachinHazira Road, Surat-394510,
Gujarat
M/s. Denex International,
812, G1/31, RIICO Industrial
Area, Bhiwandi Distt. Alwar
(Rajasthan)
M/s. TTK Healthcare Ltd.,
(Ortho Division), No. 290,
SIDCO Indutsrial Estate,
Ambattur, Chennai-98
M/s. Sahajannad Medical
Technologies Pvt. Ltd., Plot
No. 168/96/A, Dabhel
Industrial Co-operative
Society Ltd., M.G. Udyog
Nagar, Dabhel, Daman396210
M/s. A.I. Optics Ltd., B 45 &
B 46 (Ne No. 24 & 26) Vallalar
Street, MMDA Colony,
Arumbakkam, Chennai-106
71.
72.
73.
74.
1.
2.
3.
4.
5.
6.
7.
8.
9.
1.
2.
KD-Fix
KD-Fix MONO
KD-Fix Solo
KD-Fix Quick
KD-Fix Quick Mono
KD-Fix Quick Solo
KD-Fix Safety
KD-Fix Safety Mono
KD-Fix Safety Solo
Sirolmus Eluting Coronary Stent System (DES)
Sirolimus Based Coronary Bifurcation Stent System
Mfg Lic in Form 28 vide no.
627-B (H) (valid up to
05/03/2016)
Mfg Lic in Form 28 vide no.
G/28/1396
1. I.V. Cannula ISO 10555 Part V – Dxflon, Vasoflo, Zicath, Dxcan, Mfg Lic in Form 26 vide no.
Pedican, Atlas, Azivac
2335 dated 31.08.2016
1.
Modular Tibial Platform-(Sterile)
2. Mobile Bearing Mark 3R-(Sterile)
Mfg Lic in Form 28 vide no.
TN00002456 dated
13/07/2009 upto 12/07/2014
1. Flex-The Millennium Coronary Stent System
2. SFX-108-The Millennium Coronary Stent System
3. Coronnium® -Cobalt Chromium Coronary Stent System
4. IndoCore® -Cobalt Chromium Coronary Stent System
5. Infinnium® -Paclitaxel Eluting Coronary Stent System
6. Indolimus® - Cobalt Chromium Sirolimus Eluting Coronary
Stent System
1. PMMA Intraocular Lens - Appalens
2. Hydrophilic Foldabale Intraocular Lens – Acryfold, Multidiff,
Naspro, Supraphob
Mfg Lic in Form 26 vide no.
DD/537 dated 16/05/2007
upto 15/05/2017
Mfg Lic in Form 28 vide no.
TN 00002548 dated
16/02/2009 upto 15/02/2014
75.
76.
M/s. Inor Medical Products
Ltd., Plot No. 303/304,
G.I.D.C, Gundlav, Dist.
Valsad-396035
M/s. Alpha Medicare &
Devices Pvt. Ltd., 97, Alpha
Estate Near Abad Estate,
Opp. Kashiram Textile Narol,
Ahmedabad-382405, Gujarat
1. INOR/ INOR XL (Total Knee System (Hap Coated)) –Femoral
Components
2. INOR/ INOR XL (Hip System (Hap Caoted))- Bimod Modular
Hip System, Bimod (ess/ Modular/ Modhip) Straight Stems
1. Sterile Closed Wound Drainage
Mfg Lic in Form 28 vide no.
G/28/1313 dated
18/08/2009
Mfg Lic in Form 28 vide no.
G/28/1359 valid upto
06/12/2015
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