Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical Devices
(Jan. 2012 to Dec. 2012)
# / Name of the Manufacturer /Product Licenced by CLAA
/ Manufacturing Licence No. & Validity1. / M/s. Sony Surgical Private Limited, Plot No. 68, New GIDC, B/h Maxwell Industries, Umergaon, Distt-Valsad / 1. Dynamic Compression Hole + 44 / Mfg Lic in Form 28 vide no. G/28/1394 (23/11/2011 to 22/11/2016)
2. / M/s. Bhartiya Surgicals, Pahelwan Bidiwala Compound, Dafnala Road, Shahibag, Ahmedbabad-380004 / 1. Sterile Disposable Single Use “Scalp Vain Set”
2. Catheter Sterile Disposable Single Use “Suction catheter”
3. Catheter Sterile Disposable Single Use “Infant Feeding Tube”
4. Catheter Sterile Disposable Single Use “Ryle’s Tube
5. Catheter Sterile Disposable Single Use “Urethral catheter”
6. Catheter Sterile Disposable Single Use “Gibbon’s Catheter”
7. Sterile Disposable Single Use “Infant Mucous Extractor” / Mfg Lic in Form 28 vide no. G/28/1389 (29/09/2011 to 28/09/2016)
3. / M/s. SM Health Care Products Private Limited, B-113, Sec-2, DSIIDC, Bawana Industrial Area, Delhi-110039 / 1. Catheter & Stent
2. Needles
3. Guide Wire
4. Blood Tubing Set / NIL
4. / M/s. Surgimedik Healthcare, Surgimedik House, Plot No # 223, Surat Special Economic Zone, Sachin, Surat-394230 / 1. Surgimedik Urological Catheter
2. Surgimedik Gynecological Catheters
3. Surgimedik Nehprological Catheter
4. Surgimedik Gastroenterological Catheters
5. Surgimedik Radiological Catheters / 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 / 1. Single Piece PMMA Intraocular Lens
2. Single Piece PMMA Aspheric Square EDGE Intraocular Lens
3. Hydrophilic Acrylic Foldable Intraocular Lens
4. 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 / Mfg Lic in Form 28 vide no. TN00003111
6. / M/s. Nano Therapeutics Private Limited, D-54/2 Hoziwala Industrial Estate, Sachin, Surat, Gujarat-394230 / Cardiac Stent / Mfg Lic in Form 28 vide no. G/28/1395 (12/12/2011 to 11/12/2016)
7. / M/s. Envision Scientific Private Limited, 1-3 Silver Palm, 11 Nr. Sneh Milan Garden, Nanhura, Surat, Gujarat / Drug Eluting Balloon Catheter / Mfg Lic in Form 28 vide no. G/28/1396 (19/12/2011 to 18/12/2016)
8. / M/s. Yogeshwar Implant Private Limited, D-2 Kothari Compound-5 Air, Thikujini Wadi Road, Manpada, Thane (W), Maharashtra / Non Sterile Orthopaedic Implant / Mfg Lic in Form 28 vide no. KD-504 (03/02/2012 to 02/02/2017)
9. / M/s. G. Surgiwear Limited, Rasoolpur, Jahanganj, Shahjahanpur-242001, UP / 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, Distt-Thane-421506, Maharashtra / 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 / Mfg Lic in Form 28 vide no. KD-505 (06/02/2012 to 05/02/2017)
11. / M/s. Dr. Surgical, J-1024, I.I.D. Khushkhera Industrial Area, Bhiwandi, Distt-Alwar, Rajasthan / 1. Guide Wire
2. Chest Drainage Catheter
3. Hemodialysis Catheter
4. Diasnostic Catheter
5. Cath Labs Kit
6. Introducer Sheath / Mfg Lic No. NIL and Validity NIL
12. / M/s. Poly Medicure Limited, Plot no. 115, HSIDC Sector-59, Ballabgarh, Distt-Faridabad, Haryana-121004 / 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. 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 Estate-01, Faridabad-Haryana / 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)
15. / 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 / 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)
16. / M/s. MIV Therapeutics India Private Limited, 136B, Surat Special Economic Zone, Diamond Park, GIDC, Sachin, Surat, Gujarat / 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)
17. / M/s. Relisys Medical device Lilmited, Sy. No. 312, Pocharam Road, Mangalpally Village, Ibrahimpatnam Mandal, ranga Reddy Distt-501510 / 1. Cardiac Stents, (ETO Sterilized) Legend
2. Cardiac Stents, (ETO Sterilised) Legend MINI
3. Cardiac Stents (ETO Sterilised) Legend V
4. Cardiac Stents (ETO Sterilised) Cobal + C / Mfg Lic in Form 28 vide no. 19/RR/AP/2006/MD/R (29/11/2011 to 28/11/2016)
18. / M/s. Yogeshwar Implants India Private limited, D-2 Kothari Compound, 5 Acres-Thikujni Wadi Road, Manpada Thane (W) / 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. / M/s. George Philips Medical Engineering Private Limited, B-43, MIDC, Anand Nagar, Additional Ambarnath, Distt-Thena-421506 / 1. Disposable Perfusion sets
2. Disposable Perfusion sets/IV Cannula
3. Disposable Hypodermic Needle
4. IV Cannula
5. Catheters / Mfg Lic in Form 28 vide no. KD-505 (valid up to 05/02/2017)
20. / M/s. Medi Plus India Limited, 1261, 1262, MIE, Bhadurgarh, Haryana-124507 / 1. 3-way stop cock
2. Extension Tube
3. 3-way stop cock with Extension tube / Mfg Lic in Form 28 vide no. 646 B (H) (valid up to 31/05/2012)
21. / M/s. Hindustan Syringes & Medical devices Limited, 174, Sec-25, Ballabhgarh, Faridabad-121004 / 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 / Mfg Lic in Form 28 vide no. 636-B (H) (30-08-2011 to 29/08/2016)
22. / M/s. Bio-Med Healthcare Product Private Limited, Plot No. 62-65, Sector-6A, SIDCUL, Ranipur, Haridwar-249403 / IV Cannula / Mfg Lic in Form 28 vide no. 123/UA/SC/P-2007 (valid up to 01/11/2012)
23. / M/s. Lars Medicare Private Limited, Kila No. 16 & 17, Village Sultanpur, G.T. Road, Bahalgarh Chowk, Distt-Sonepat-131021 / VYTAP / Mfg Lic in Form 28 vide no. 660-B-H (valid up to 03/02/2013)
24. / M/s. Polymer technologies International (EOU), Block No. 310/C, Village-Dabhasa, Tal. Padra Dist-Vadodara-391440 / 1. PMMA Intraocular Lens (Sterile)
2. Yellow PMMA Intraocular Lens (Sterile)
3. Foldable Hydrophilic Acrylic Intraocular lens (Sterile)
4. Foldable Hydrophilic Acrylic Intraocular lens (Sterile)
5. Foldable Hydrophilic Yellow Acrylic Intraocular Lens (Sterile)
6. Foldable Hydrophilic Acrylic Intraocular Lens (Sterile)
7. Foldable Hydrophobic Intraocular Lens (Sterile)
8. Foldable Hydrophobic Yellow Intraocular Lens (Sterile) / Mfg Lic in Form 28 vide no. G/1321 (18/12/2009 to 17/12/2014)
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 / 1. Scalp Vein Infusion Set (Needle size 20G)
2. Scalp Vein Infusion Set (Needle size 21G)
3. Scalp Vein Infusion Set (Needle size 22G)
4. Scalp Vein Infusion Set (Needle size 23G)
5. Scalp Vein Infusion Set (Needle size 24G) / Mfg Lic in Form 28 vide no. G/28/1409 (valid up to 13/03/2017)
26. / M/s. Global Medikit Limited, Khasra No. 323 (MI), Central Hope Town, Camp Road, Selaqui dehradun, Uttrakahand / 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 / Mfg Lic in Form 28 vide no. 18/UA/SC/P-2009 (valid up to 23/03/2014)
27. / M/s. Poly Medicure Limited, Plot No. 115-116, HSIDC, Sector-59, Ballabgarh, Distt-Faridabad-121004 / Introducer Cannula + 167 / Mfg Lic in Form 28 vide no. 627-B (H) (valid up to 05/03/2016)
28. / M/s. Veritas Bioventions Private Limited, Plot No. 5305, Phase-IV, GIDC, Vapi-396195 / Elimin8-R / Mfg Lic in Form 28 vide no. G/28/1379 (valid up to 21/07/2016)
29. / M/s. SQL Surgical (India) Private Limited, Surampalli, Ganavaram (M), Krishan Distt-AP / 1. Bone Plates
2. Bone Screws
3. Bone Nails
4. Prosthesis
5. Wires-Pins
6. Spine Implants
7. Locking Plates
8. Maxellofacial Implants / Mfg Lic in Form 28 vide no. 37/KR/AP/2009/S/G (valid up to 14/10/2014)
30. / M/s. Translumina Therapeutics LLP, Plot No. 9, Pharmacity, Selaqui, Dehradun-248197 / Sirolimus Drugs Eluting CoCr Coronary Stent System / Mfg Lic in Form 28 vide no. 6/UA/SC/P-2011 (valid up to)
31. / M/s. Unique ortho Systems private Limited, 648, GIDC Waghodia, Distt-Vadodara / External Fixetor
External Fixetor Screw / Mfg Lic in Form 28 vide no. G/28/1419 (29/05/2012 to 28/05/2017)
32. / M/s. Poly Medicure Limited, Plot No. 104-105, Sector-59, HSIDC Industrial Area, Ballabgarh, Faridabad-121004 / 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. 644-B-H (24/05/2007 to 23/05/2012)
33. / M/s. Siora Surgicals Private Limited, Plot No. 1792, HSIDC Industrial Estate, rai Sonepat, Haryana / 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
34. / M/s. Multi Medics, Plot No. 28, HPSIDC Phase-III, Baddi, Distt-Solan-173005 / E-Magic Plus / Mfg Lic in Form 28 vide no. MB/10/836 (valid up to 21/01/2016)
35. / M/s. iLife Medical Devices Private Limited, #86, Sector-56, Phase-IV, I.E. Kundli Sonepat-131028 / Neotec / Mfg Lic in Form 28 vide no. 673-B-H (valid up to 12/08/2014)
36. / M/s. Poly Medicure Limited, Plot No. 115-116, HSIDC, Sector-59, Ballabgarh, Distt-Faridabad-121004 / IV Cannula & Catheters / Mfg Lic in Form 28 vide no. 627-B-H (valid up to 05/03/2016)
37. / M/s. Newtech Medical devices, B-198, 2nd Floor, Okhla Industrial Area, Phase-I, New delhi-110020 / 1. Medcomp Dialysis Catheter
2. Medcomp Dialysis Catheter Kit
3. Introducer Sheath Catheter
4. Dilation Catheter / Mfg Lic in Form 28 vide no. S (0007)11/MD (valid up to 09/08/2016)
38. / M/s. Bio Med Healthcare Products Private Limited, 30 DLF Industrial Estate-1, Faridabad / IV Cannula with/without wings & Injectable Port / Mfg Lic in Form 28 vide no. 651-B-H (valid up to)
39. / M/s. Vitromed Healthcare, A-27, Industrial Estate, 22 Godman Jaipur-302006 / 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 / Mfg Lic in Form 28 vide no. Raj-2346 (valid up to 07/02/2017)
40. / M/s. Hollister India Private Limited, Plot No. #27, Sector-5, Phase-II, HSIDC Growth Center, Bawal, Distt-Rewari-123501 / Catheter (Sterile) and Catheters (non Sterile) / Mfg Lic in Form 28 vide no. 676-B-H (valid up to)
41. / M/s. Devon Innovations Private Limited, Plot No. 27-A, Near State Bank of India, Electronic City, Phase-I, Hosur Road, Bangalore-560100 / 1. Orthopaedic Implants
2. Catheters / Mfg Lic in Form 28 vide no. KTK/28/395/2009 (valid up to 15/06/2016)
42. / M/s. Universal Ortho Systems, 926/2, 927/1, GIDC Waghodia, Distt-Vadodara-391760 / 1. Bone Screws
2. Bone Plates
3. Nails
4. Pins & Wires
5. Joint Replacement Prosthesis
6. Spinal Implants / Mfg Lic in Form 28 vide no. G/28/1414 (19/04/2012 to 18/04/2017)
43. / M/s. Devparv Surgico, D/1/C/ Diamond Park, GIDCV, naroda Ahmedabad-382330 / 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