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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. Validity of the Registration Certificate
1 M/s Sahajanand Medical Technologies Pvt. Ltd., Sahajanand House, Parsi Street, Saiyedpura, Surat- 395003, Indai
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 31-12-2013
2 M/s VSY Ophthalmic India Pvt. Ltd., 860/1-B, GIDC Estate, Nr. ABB Goods Gate, Makarpura, Vadodara- 390010, Gujarat
M/s VSY Biotechnology-VSY Biyoteknoloji ve IIac San. A.S. of Ataturk Mah., Sulun c., Kamilbey Sok No. 4, Atasehir, Istanbul, Turkey
1. ACRIVA Ultra Definition Intra Ocular Lents
2. ACRIVA Reviol Multifocal Intra Ocular Lens
3. OCUVA Aspheric Intra Ocular Lens
4. OCUVA Spheric Intra Ocular Lens
31-824-MD/2010-DC MD-824 31-12-2013
3 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 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
1. Open Pivot Heart Valve2. Open Pivot Aortic Valved
Graft (AVG)
31-892-MD/2010-DC MD-892 31-12-2013
4 M/s B. Braun Medical India Pvt. Ltd., 5th Floor, East Quadrant,
M/s B. B raun Melsungen AG, Carl-Braun- Strasse 1,
1. Intrafix-IV Infusion administration sets vented for pressure and
31-146-MD/2006-DC (Re-Registration 2009) (End. 1)
MD-146 30-11-2012
1
The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai- 400051
34212 Melsungen, Germany
gravity infustions
5 M/s Edward Lifesciences (India) Pvt. Ltd., E.F. 201-204, Remi Biz Court, Plot No. 9, Off Veera Desai Road, Andheri West, Mumbai- 400058
M/s Edward Lifesciences LLC, One Edwards Way, Irvine CA, USA 92614-5686
1. Carpentier-Edwards Bioprosthetic Valved Conduit
2. Edwards MC Tricuspid Annuloplasty System
31-93-MD/2006-DC (Re-Registration 2010) (End. 1)
MD- 93 31-01-2013
6 M/s Boston Scientific International B.V., 100A, The Capital Court, Olof Plame Marg, Munirka, New Delhi- 110067
M/s Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts 01760-1537, USA having factory premises at M/s Boston Scientific Ireland Ltd., Ballybrit Business Park, Galway, Ireland
1. WallFlex Enteral Colonic/ Duodenal Stent System
31-41A-MD/06-DC (End. 2)
MD-41A 31-03-2013
7 M/s Abbott Medical Optics Pvt. Ltd., No. 91, G.N.T. Road, Madhavaram, Chennai- 600110
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
1. Blink Intensive Tears 31-737-MD/2009-DC MD-737 31-12-2013
8 M/s B. Braun Medical (India) Pvt. Ltd., 5 th Floor , East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra
M/s B. Braun Medical, 204 Avenue du Marechal Juin-BP 331, 92107 Boulogne, Cedex, France having factory premises at
Needles for Implantable access ports
1. Surecan2. Cytocan
31-393-MD/2007-DC (Re-Registration 2010)
MD- 393 31-12-2013
2
(East), Mumbai- 400051
M/s B. Braun Medical Industries Sdn. Bhd., Bayan Lepas Free Industrial Zone, 11900 Penang, Malaysia
9 M/s RFCL Ltd., A-3, Okhla Industrial Area, Phase-I, New Delhi
M/s Biokit S.A. Can Male s/n, 08186, Llica d Amunt, Barcelona, Spain
1. Bioelisa HBsAg 3.0 6-6/CD-35/2009-DC (Re-Reg 2009) (End 01)
CD-31 31-05-2012
10 M/s Epsilon Eye Care Pvt. Ltd., 6B-301 Shweta Asha Nagar, Western Express Highway, Kandivali East, Mumbai - 400101
M/s Aaren Scientific Inc., 4290 E. Brickell Street, Building A, Ontario, California 91761 USA
1. Oii PMMA (Intraocular Lenses)
2. Oii Heparin PMMA (Intraocular Lenses)
3. Oii Biovue (Intraocular Lenses)
31-14-MD/2006-DC (Re-Registration 2009)
MD-14 30-06-2012
11 M/s Becton Dickinson India Pvt. Ltd., 5th Floor, Singnature Towers II, South City-1, Gurgaon- 122001 Haryana
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
1. Alcohol Swab 31-825-MD/2010-DC MD-825 14-12-2013
12 M/s. Labindia Healthcare Private Limited, 372 Udyog Vihar, Phase- 2, Gurgaon, 122016, Haryana
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. VAC WhiteFoam Small & Large
31-792-MD/2010-DC MD- 792 31-12-2013
13 M/s. St. Jude Medical India Private Limited,
M/s. St. Jude Medical, 14901 De Veau Place
1. Engage Family Introducers
31-22-MD/2006-DC (Re-Registration
MD- 22 30-06-2012
3
A&B, 2nd Floor, “Brij Tarang”, Greenlands, Begumpet, Hyderabad 500016
Minnetonka, MN 55345-2126 USA
2009) (End 3)
14 M/s Baxter (India) Pvt. Ltd., 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase II, Gurgaon 122002
M/s Baxter Healthcare Corporation 1900 N. Highway 201 Monutain Home, ar 72653-2497
1. Minicap Extended Life Transfer Set
31-730-MD/2009-DC MD- 730 31-12-2013
15 M/s Tyco Healthcare India Pvt. Ltd., “DOSHI TOWERS” 6th Floor, Doshi twoers, Poonamallee High Road, Chennai- 600010
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
16 M/s. Globus Medical India Private Limited, New No. 3, Sriram Nagar, South Street, Alwaret, Chennai- 600018
M/s. Globus Medical, Valley Forge Business Centre 2560 General Armistead Avenue Andubon, PA 19403, USA
1. Microfuse Bone Void Filler (Spine Indications), Sterile
2. H-Link Integrated Rod3. Transition Stabilization
System STERILE Implant4. Nilo Corpectomy Spacer5. Patriot Singature TLIF
Spacer6. Revolve Stabilization
System7. VIP Anterior Cervical
Plate System8. Corridor Fixation System
31-277-MD/2006-DC (Re-Registration 2010) (End 1)
MD- 277 28-02-2013
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, USAHaving factory premises at M/s.
1. Curved Applicator Tip 8cm & 10cm
31-734A-MD/2009-DC (Re-Registration 2011)
MD-734A 14-01-2014
4
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, Thane-Bhiwandi Road, Thane-421302
M/s. Smith & Nephew Orthopaedics Limited, 1 Kingmaker Court, Warwick Technology Park, Gallows Hill, 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
Birmingham Hip Resurfacing System
31-441-MD/2008-DC (Re-Reg. 2010)
MD-441 31-03-2014
19 M/s. Prime Surgicals, 3/15 Asaf Ali Road, New Delhi-2
M/s. Curamed Opthalmics, Voorstraat 57, 4132 AN, Vianen, Netherlands
Curamed Intraocular Lens Hydrophilic Acrylic
31-152-MD/2006-DC (Re-Reg. 2010)
MD-152 14-02-2014
20 M/s. Alpha and Omega Diagnostics India Limited, Rajmahal 13, Bhuleswar Road, Mumbai-400002
M/s. Labotect GmbH, labour technik-Gottingen, Wille-Eicher Str. 25, D-37079 Gottingen, Germany
Embryo Transfer Catheter 31-269-MD/2006-DC (Re-Reg. 2010)
MD-269 14-02-2014
21 M/s. DePuy Medical private Limited, 64-66 Senapati Bapat Marg, mahim, Mumbai-400016
M/s. DePuy Orthopaedics, Inc PO BOX 988, 700 Orthopaedic Drive, Warsaw, Indiana 46581-0988, USA having factory premises at M/s.
1. PFC Tibial Trays-Standard & Modular
2. Apex Hole Eliminator3. Articul/Eze Heads4. Duraloc Hip System-Poly
Liners & Cups5. PFC Sigma Toal Knee
Replacement
31-852-MD/2010-DC MD-852 31-01-2014
5
Johnson & Johnson Medical (Suzhou) Limited, No. 299, Chang Yang Street, Suzhou Industrial Park, Suzhou Jiangsu 215126, China
6. Global Shoulder Systems7. Screws: Cortical Screws,
Cancellous Screws and pinnacle Screws
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
M/s. CID S.r.l., Strada per Crescentino snc, 13040, Saluggia (VC), Italy
1. Janus Optima Carbostent2. Brio Pegaso SCRX3. Pro HP Pegaso
31-06-MD/2006-DC (Re-Reg. 2009) (End 01)
MD-06 14-04-2013
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, D-22851 Norderstedt, Germany
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 non-absorbable sutures
31-816 (FF-319)-MD/08-DC (Re-Reg. 2011)
MD-816 (FF-319)
14-02-2014
24. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
M/s. Medinol Limited, PO Box 45026, Back Tech Bldg, 4th Floor, Har-Hotzvim B, Hartom Street 8, Jerusalem 91450, Israel
PRESILLION Plus CoCr Coronary Stent on RX System (Sterile) (PRESILLION Plus Stent System)
31-788-MD/2010-DC MD-788 14-02-2014
25. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-
M/s. Cordis Corporation, 14201, North West 60th
Emboli Capture Guidewire System: Angioguard XP and Angioguard RX
31-859A-MD/2010-DC MD-859A 31-01-2014
6
400036 Avenue, Miami Lakes, Florida 33014, USA having factory premises at M/s. Lake Region Medical, 340 lake Hazeltine Drive Chaska, MN 55318, USA
26. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
M/s. Codman & Shurtleff Inc, 325 Paramount Drive Raynham, Massachusetts, USA
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
27. 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
1. Endeavor Zotarolimus Eluting Coronary Stent System
2. Endeavor-Sprint-Zotarolimus-Eluting RX Coronary Stent System
3. Endeavor Resolute Zotarolimus Eluting Coronary Stent System
4. Assurant Cobalt Over-The wire lilac Stent System
31-64-MD/2006-DC (Re-Reg. 2009)
MD-64 31-07-2012
28. 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
1. Talent Abdominal/AUI Stent graft with Xcelerant Hydro Delivery System
2. Valiant Stent Graft with Xcelerant Delivery System
31-64-MD/2006-DC (Re-Reg. 2009) (PT-IV)
MD-64 31-07-2012
29. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-
M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at
1. Launcher Guide Catheter2. Vascular Diagnostic
Catheter (a) SiteSeer(b) ProFlow
3. PTCA Guidewires
31-63-MD/2006-DC (Re-Reg. 2009)
MD-63 31-08-2012
7
Ghatkopar Link Road, Andheri East, Mumbai-400093
M/s. Medtronic Vascular 37A, Cherry Hill Drive, Danvers, MA 09123, USA
4. Angiographic Guidewires5. Export and Export XT Aspiration Catheters6. Guardwire Occlusion and Aspiration System7. Woven Angiographic Catheters8. Sherpa NX Guiding Catheters
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 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 46582
1. Atlas Cable System2. Brayan Cervical Disc
System3. MAV Motion Segment
Replacement-A-MAV & O-MAV Artificial Disc Replacement
4. LT-CAGE Lumber Tapered Fusion Device
5. Prestige LP Cervical Disc System
6. ATLANTIS Anterior Cervical Plate System
7. BASIS Spinal System8. CD HORIZON Spinal
System9. Pyramesh C Mesh10. Pyramesh Implant
System11. Vertek Reconstruction
Implants12. Zephir Anterior Cervical
Plate System13. Dynamic Compression
SMA Stapple System14. TSRH Spinal System15. UCSS Universal
Cannulated Cortical Bone Screw
16. Colorado 2 Spinal System
31-69-MD/2006-DC (Re-reg. 2009)
MD-69 31-01-2013
8
31. 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. C.R. Bard Inc, 289 Bay Road, Queensbury, NY 12804, USA
Rashkind Septostomy Catheter 31-341-MD/2007-DC (Re-Reg. 2010)
MD-341 14-08-2013
32. 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 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
Infuse Bone Graft 31-69B-MD/2006-DC (Re-Reg. 2009)
MD-69B 14-04-2013
33. 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 vascular, 37A, Cherry Hill Drivew, Danvers, MA 09123, USA
Total 5 Products 31-63-MD/2006-DC (Re-Reg. 2009) (End 01)
MD-63 31-08-2012
34. 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
Sprinter Legend Over the Wire Balloon Dilatation Catheter
31-64-MD/2006-DC (Re-Reg. 2009) (PT-V)
MD-64 31-07-2012
9
35. M/s. Allergan Healthcare India Private Limited, Level 2, Presige Obelisk, No. 3 Kasturba Road, Bangalore-560001
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
Hyaluronic Acid with Lidocaine 31-483-MD/2008-DC (End 01)
MD-483 31-05-2012
36. M/s. KMS Medisurgi Private Limited, 44, Mangaldas Road, Bulakhidas Building, Ground Floor, Mumbai-400002
M/s. Mascia Brunelli s.p.a. Vle. Monza, 272.20128 Milano-Italy
Haemostatic Gelatin Sponge (Cutanplast)
6-4/FF/35/04-DC (PT) (Re-Reg. 2010)
FF-276 31-01-2014
37. M/s. S.R. International, 801, Manjusha, 57 Nehru Place, New Delhi-110019
M/s. Arcadophta Sarl, 11, rue Antoine Ricord, 31100 Toulouse, France
Arceole Set Multidose Kit (C3F7, SF6, C2F6) (Intraocular Gases)
6-4/FF/40/06/DC (Re-Reg. 2010) (End 01)
FF-425 30-09-2013
38. M/s. B. Braun Medical India Private Limited, 5th Floor, East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai-400051
M/s. B. Braun Melsungen AG, Carl-Braun-Str. 1, 34212, Melsungen, Germany having factory premises at M/s. B. Braun Melsungen AG, Vascular Systems, Sieversufer 8, 12359, Berlin, Germany
Arteriofix-Arterial Catheter Sets 31-687-MD/2009-DC (End 02)
MD-687 30-11-2012
39. M/s. Boston Scientific International B.V., 100A, The Capital Court, Olof Plame Marg, Murirka, New Delhi-110067
M/s. Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts 01760-1537, USA having factory premises at M/s. Availmed S.A. de C.V. A. Pasaeo
1. Wiseguide Catheter 2. Impulse Angiographic
Catheter 3. Mach 1 Guide Catheter
31-166-MD/2006-DC (Re-Reg. 2009)
MD-166 14-02-2014
10
Reforma No. 8950 Int. G1ByG1H, Col. Fraccionamiento Rubio, C.P. 22116, Le Mesa, Tijuana, Baja, California
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
M/s. Smith & Nephew Inc, Orthopedic DEivision, 1450 Brooks Road, Memphis, TN 38116, USA
1. Echelon Hip System 2. Synergy Hip System 3. Reflection Acetabular
System 4. Genesis II Knee System 5. VersaBond and
VersaBond AB Bone Cements
6. Journey Knee System 7. Legion Knee System 8. Tandem Hip System 9. R3 Acetabular System
31-779-MD/2010-Dc MD-779 14-02-2014
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
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]
31-733-MD/2009-Dc MD-733 31-01-2014
42 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, 17511 Armstrong Avenue Irvine, California 92614, USA
Floseal Endoscopic Applicator 31-719-MD/2009-DC MD-719 14-02-2014
43. M/s. Event Medi Systems, 218 Vishal Towers, District centre, Janakpuri, New Delhi-110058
M/s. Conic Vascular Technology, SA Via G. Curti, 5 CH-6900 Lugano, Switzerland
1. Clever PTCA Balloon Catheter
2. Conic One PTCA Balloon Catheter
31-798-MD/2010-DC MD-798 31-01-2014
11
44. M/s. Alcon Laboratories India Private Limited, Unit No. 502, Tower “D”, 5th
Floor, RMZ Infinity, Benniganahalli, Old Madras Road, Bangalore-560016
M/s. Alcon Laboratories Irelands Limited,m Cork Business and technology Park, Model Farm Road, Cork Ireland
AcrySof IQ ReSTOR Multifocal Intraocular lens
31-364-MD/2006-DC (Re-Reg. 2010) (End 01)
MD-364 14-09-2013
45. M/s. Edwards Lifesciences India Private Limited, E.F. 201-204 Remi Biz Court, Plot o. 9, Off Veera Desai Road, Andheri (W), Mumbai-400058
M/s. Edwards Lifesciences Technology Sarl, State Road 402, KM 1.4, Industrial Park, Anasco, Puerto Rico 00610-1577
1. Advance venous Access products
2. AVA 3Xi Devices3. Central Venous Oximetry
Catheters (PreSep Oximetry Catheters)
4. Swan-Ganz Cath Lab (Non-Thermodilution)
5. Swan-ganz Oximetry and Volumetric Catheters (Oximetry Catheters)
6. Swan-Ganz CCO and CCOmbo Catheters (Swan-Ganz continuous cardiac output (CCO)) Thermodilution Catheters
7. Fogarty Catheters (Embolectomy) Catheters, Thrombectomy Catheters, Adherent Clot Catheter)
31-91-MD/2006-DC (Re-Reg. 2009) (End 02)
MD-91 31-03-2013
46. M/s. St. Jude Medical India private Limited, A & B, 2nd Floor, Brij Tarang, Greenlands, Begumpet, Hyderabad-500016
M/s. Hansen Medical Inc, 800 East Middlefield Road, Mountain View CA 94043
Artisan Control Catheter 31-812-MD/2010-DC MD-812 31-01-2014
47. M/s. Heart Beat Intervention Private
M/s. Minvasys, 7, rue du Fosse Blanc-92230
1. PTCA Catheters2. PTA Catheters
31-275-MD/2007-D (Re-Reg. 2010)
MD-275 14-01-2014
12
Limited, 9, Lower Ground, Narayan Darshan Apartment, Opp. Rupam Cinema, Salabatpura, Surat-395002, Gujarat
Genevilliers, France 3. Intra Coronary Stents
48. M/s. Access Devices, 28, 12th Cross, Indiranagar 1st Stage, Bangalore-560038
M/s. Districlass Medical SA, 16, Rue Paul Bert 42000 Saint Etienne-France having factory premises at M/s. Districlass Medical SA, B.P. 14, 69970 Chaponnay, France
Districath Implantable Catheter Ports
31-97-MD/2006-DC (Re-Reg. 2010)
MD-97 14-02-2014
49. M/s. Vishal Surgical Equipment Co. Private Limited, Melaram Complex, 23, Wallers Road, Chennai-600002
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, D-78570, Muelhelm a.D./Germany
1. Screws, Plates, mesh, Distractors of various sizes-Titanium
2. Resorbx Screws, Plates, Mesh, Sonic-weld RX Pins
3. Screws, Plates, Mesh, Distractors of various sizes-Titanium
4. Screws, Plates, Mesh, Distractors of various sizes-Stainless Steel
31-390-MD/2007-DC (Re-Reg. 2010)
MD-390 14-02-2014
50. M/s. Evolutis India Private Limited, 185-R, Alhad, 1s Floor, P.K. Road, Mulund (W), Mumbai-400080
M/s. Evoluis, Avenue De La Liberation-42720, Briennon, France
Total 8 products 31-282-MD/2006-DC (Re-Reg. 2010)
MD-282 14-02-2014
51. 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 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
13
52 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 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
53. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
M/s. Ethicon LLC, Road 183 Km 8.3 San Lorenzo, Puerto Rico 00754
1. Prolene (Polypropylene) Soft Mesh
2. Gynecare Gynemesh PS
31-738(A)-MD/2009-DC End 01
MD-738(A)
28-02-2013
54. 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 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
Integrity Rapid Exchange Coronary Stent System
31-64-MD/2006-DC (Re-Reg. 2009) (End 06)
MD-64 31-07-2012
55. M/s. Hansraj Nayyar Medical India, 1416, Maker Chambers V, Nariman Point, Mumbai-400021
M/s. Smiths Medical ASD Inc, 201 West Queen Street, Southington, Connecticut 06489, USA
ProtectIV Plus Safety I.V. Catheter
31-809-MD/2010-DC MD-809 14-02-2014
56. M/s. baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002
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
57. M/s. Advanced Therapeutics Prtivate Limited, Plot #1, 2nd
M/s. Kaneka Corporation, 2-4-3-Chome, Nakanoshima,
1. Throumbuster II2. Fortis II (Balloon
Catheter)
31-187-MD/2006-DC (Re-Reg. 2011)
MD-187 28-02-2014
14
Floor, LSC New Rajinder Nagar, New Delhi-110060
Kita-ku, Osaka 530-8288, Japan having factory premises at M/s. Kaneka medix Corporation, kanagawa Plant, 225-1, Aza Deguchi, Yamakita, yamakita-Machi-Ashigara-Kami-Gun, Kanagawa, 258-0113, Japan
3. Crusade KMF0114A4. Ichiban-Yari 380-1T, 380-
3T
58. M/s. TotipotentSC Scientific Product Private Limited, No. Y-23, 3rd Street, Anna Nagar, Chennai-600040
M/s. Thermogenesis Corp., 2711 Citrus Road, Rancho Cordova, California-95742, USA
Res-Q 60 BMC 31-826-MD/2010-Dc MD-826 28-02-2014
59. M/s. Teleflex medical Private Limited, No. 19, Harrington Road, Chetpet, Chennai-600031
M/s. Willy Rusch GmbH, Willy-Rusch-Strasse 4-10, 71394 Kernen, Germany
1. Tiemann Catheter2. Deleforsse Catheter3. Embolectomy Catheter4. Silkolatex T-Tube
31-776-MD/2010-DC MD-776 28-02-2014
60. M/s. Yogi Kirpa Medi-Chem Private Limited, Amar Building, 355,56, Central Avenue Road, Chembur, Mumbai-400071
M/s. Heraeus Medical GmbH, Philipp-Reis-Str. 8/13, 61273 Wehrheim, Germany
1. Bone Cement2. Bone cement with
Gentamycin
31-376-MD/2007-DC (Re-Reg. 2010)
MD-376 31-03-2014
61. 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 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
1. Sprinter rapid Exchange Balloon Dilatation Catheter
2. Sprinter legent RX Balloon Dilatation Catheter
3. Melody Transcatheter Pulmonary Valve
31-381-MD/2007-DC (Re-Reg. 2010)
MD-381 14-02-2014
15
10510, Parque Industrial EI Lago, Tijuana, B.C. 22570< Mexico
62. M/s. Nobel Biocare India Private Limited, 103AB, 1?f, Fortune 2000 bandra-Kurla Complex, bandra (E), Mumbai-400051
M/s. Nobel Biocare USA LLC 22715 Savi Rusch Parkway Yorba Linda, CA 92887
Total 6 Products 31-218-MD/2007-DC (Re-Reg. 20100
MD-218 28-02-2014
63 M/s India Medtronic Pvt. Ltd., 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai- 400093
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
Complete SE lilac Stent System 31-64-MD/2006-DC (Re-reg. 2009) End 4
MD-64 31-07-2012
64. M/s. Faith Biotech Private Limited, E-107, Lajpat Nagar,-1, New Delhi-110024
M/s. Micro Vention Inc, 1311 Valencia Avenue, Tustin, CA, USA 92780
1. Microplex Coil System (MCS)
2. Hydro Coil Embolic System (HES)
31-804 (A)-MD/2010-DC
MD-804(A)
14-03-2014
65. 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
Total 2 products 31-686(B)-MD/2009-DC (Re-Reg. 2010)
MD-686(B)
14-03-2014
66. M/s. Lifetech Scientific India Private Limited, #3, 1st Main, 3rd Floor, BDA Layout, Kodihally, HAL 2nd Stage, Bangalore-560008
M/s. Lifetech Scientific (Shenzhen) Co. Limited, Floor 3-1 Cybio Electronic Building, Langshan 2nd Street, North Area of
Total 4 Products 31-834-MD/2010-DC MD-834 14-03-2014
16
High-Tech Park, nanshan District, Shenzhen, 518057, China
67. M/s. Johnson & Johnson Limited, 30, Forjett Street, Mumbai-400036
M/s. Ethicon Inc, Route 22 West Somercille New Jersy 08876, USA having factory premises at M/s. Ethicon Inc, 655 Ethicon Circle, Cornelia, Georgia 30531, USA
Proceed Surgical Mesh 31-827-MD/2010-DC MD-827 14-03-2014
68. M/s. Zimmer India Private Limited, Plot No. B & B1, Vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016
M/s. Zimmer GmbH Sulzer Allee 8, CH 8404 Winterthur, Switzerland
1. Metasul Taper Liner2. Biolox Delta Taper Liner
31-171-MD/2006-DC (Re-Reg. 2009) End 01
MD-171 31-07-2012
69. M/s. Ophtho Equip Inc, 703, Samrueddhi, Opp. Sakar-III, Nacrangpura, Ahmedabad-380014
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
STAAR PHAKIC IOL-CollamerImplantable Contact Lens (ICL/TICL)
31-926-MD/2011-DC MD-926 14-03-2014
70. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai-400093
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,
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
17
Germany71. M/s. Teleflex Medical
Private Limited, 64, Rukmani Lakshmipathi Salai, (20 Marshalls Road), Egmore, Chennai-600008
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 International inc) 9 Plymouth Street Everett, Massachusetts 02149, USA
Intra Aortic Balloon (IAB) Catheters, Sterile
31-841-MD/2010-Dc MD-841 14-03-2014
72. M/s. MN Solutions, #26 & 27, 2nd Floor, WZ-26, Nangli Jalib, B-1, Janak Puri, New Delhi-110058
M/s. Tecres SpA, Via Andrea Doria 6 37066 Sommacampagna-VR-Italy
1. Cemex2. Cemex Genta3. Spacer4. Spacer5. Mendec
31-818-MD/2010-Dc MD-818 14-03-2014
73. M/s. Nobel Biocare India Private Limited, 103AB, 1/F, Fortune 2000, Bandra-Kurla Complex, bandra (E), Mumbai-400051
M/s. Nobel Biocare AB, P.O. Box No. 5190, SE-40226, Goreborg, Sweden having factory premises at M/s. Nobel Biocare AB, Dimbovagen 2, SE-691 51 Karlskoga, Sweden
Dental Implants1. Nobel Active (Titanium)2. Branemark System
(Titanium)3. Zygoma (Titanium)4. Nobel Replace (Titanium)5. Nobel Speedy (Titanium)6. Nobel Esthetics
(Titanium)7. Procera
31-217-MD/2007-DC (Re-Reg)
MD-217 31-03-2014
74. M/s. Hemant Surgical Industries Limited, 647, Avijah Building, Ground Floor, No. 6 & 7, Girgaum Road, Mumbai-400002
M/s. Shanghai Kindly Enterprise Developmetn Group Co. Limited, No. 18 Lan,e 668 Haujiang Road, 201803, Shanghai, China
1. Scalp Vein Set2. Hypodermic Needles3. Syringes
31-854-MD/2010-Dc MD-854 14-03-2014
75. M/s. Covidien Healthcare India
M/s. Sofradim Production 116
a. Parietexb. Parietex Composite
31-933-MD/2011-Dc MD-933 14-03-2014
18
Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
Avenue du Formans F-01600 Trevoux, Frnace
c. Parietene d. Parietene Composite
76. M/s. Kalyx India Healthcare Private Limited, No. 21, ‘F’ Block, Anna Nagar East, Chennai-600102
M/s. AAP Implantate AG, Lorenzweg 5 D-12099 Berlin, Germany
Medical Device Family: Bone Plates, Bone Screws & Wire, Bone Kit
31-835-MD/2010-DC MD-835 31-03-2014
77. M/s. Boston Scientific International BV, 100A, The Capital Court, Olof Plame, Marg, Munirka, New Delhi-110067
M/s. Boston Scientific Corporation, Boston Scientific Palace, Natick, Massachusetts 01760-1537, USA
Wingspan Stent System 31-165-MD/2006-DC MD-165 14-06-2013
78. M/s. Alcon Laboratories India Private Limited, Unit No. 502, Tower “D”, 5th
Floor, RMZ Infinity, benniganahalli, Old Madras Road, Bangalore-560016
M/s. Alcon Research Limited, 714 Columbia Avenue, Sinking Spring, Pennsyllvania, 19608, USA
Alcon Non-Absorbable Surgical Suture
31-875-MD/2010-Dc MD-875 31-03-2014
79. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai-400093
M/s. Medtronic Ireland, parkmore Business park, West Galway, Ireland having factory premises at M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN-55432, USA
Raliant Stent Graft Balloon Catheter
31-64-MD/2006-DC (Re-Reg. 2009) End 07
MD-64 31-07-2012
80. M/s. MN Solutions, #26 & 27, 2nd Floor, WZ-26, Nangli Jalib, B-1, Janak Puri, New Delhi-110058
M/s. Biomatlante, 5 rue Edouard belin, ZA Les Quatre nations, 44360, Vigneux de Bretagne, France
Bone X (Calcium Phosphate Bone Substitute)
31-800-MD/2010-DC MD-800 31-03-2014
81. M/s. Covidien M/s. Covidien IIc, 15 1. Endobronchial Tubes 31-419-MD/2008-DC MD-419 14-04-2014
19
Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Mallinckrodt Medical, Commaddy, Athlone Co. Westmeath, Ireland
2. Tracheal Tubes3. Tracheostomy Tubes
(Re-Reg. 2011)
82. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Distt-Thane, Bhiwandi
M/s. Cordis Cashel, Cahir Road, Cashel Co. Tipperary Ireland having factory premises at M/s. Cordis de Mexico SA, de CV Calle Circuito Interior Norte # 1820, Parque Industrial Salvarcar, Ciudad Juarez, Chihuahua, mexico 32575
Total 13 products 31-881-MD/2010-DC MD-881 14-04-2014
83. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
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
Closed Sunction System with accessories (Replaceable catheter, Pediatric, Neonatal)
31-418-MD/2008-DC (Re-Reg. 2011)
MD-418 31-03-2014
84. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
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
Total 9 products 31-50-MD/2006-DC (Re-Reg. 2011)
MD-50 31-03-2014
85. M/s. Covidien Healthcare India
M/s. Kendall Kenmex, A Division of Tyco
1. Trocar Catheters2. Thoracic Catheters
31-47-MD/2006-DC (Re-Reg. 2011)
MD-47 31-03-2014
20
Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
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
86. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. Kendall, A Division of Tyco Healthcare Group 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
1. 100% Silicone Folley catheters
2. Silison Thoracic Catheter
31-49-MD/2006-DC (Re-Reg. 2011)
MD-49 31-03-2014
87. M/s. MIV Therapeutics India Private Limited, 136-B, Surat Special Economic Zone, Road No. 4, Diamond Park, GIDC, Sachin, Surat-394230
M/s. Natec Medical Limited, maeva Centre, Business park, Ebene, Reduit, Mauritius
1. Tamarin Blue (Non-Sterile) PTCA Catheter
2. Filao Rx (Non Sterile) PTCA Catheter
31-326-MD/2007-DC (Re-Reg. 2010)
MD-326 31-03-2014
88. M/s. Advanced Lifesciences Private Limited, D-22, Okhla Industrial Area, Phase-I, New Delhi-110020
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
1. Diagnostic Angiographic Catheters-Performa
2. Diagnostic Angiographic Catheters-Softuch
3. Diagnostic Angiographic Catheters-Impress
4. Guide Catheters-Concierge
31-158-MD/2006-DC (Re-Reg. 2009)
MD-158 31-03-2014
21
South Velasco, Angleton, Texas 77515, USA
89. M/s. Advanced Lifesciences Private Limited, D-22, Okhla Industrial Area, Phase-I, New Delhi-110020
M/s. Merit Medical Systems Inc, 1600 West Merit parkway, South Jordan, Utah 84095, USA
1. Infusion Catheters-Fountain
2. Infusion Catheters-Mistique
31-937-MD/2011-Dc MD-937 31-03-2014
90. M/s. Teleflex medical Private Limited, Old No. 10, No. 19, Harrington Road, Chetpet, Chennai-600031
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, Asheboro, North Carolina 27203, USA
Total 8 products 31-844-MD/2010-Dc MD-844 31-03-2014
91. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. ev3 Inc, 4600 Nathan Lane North, Plymouth, MN 55442, USA
1. Protégé2. ParaMount Mini GPS
Stent System3. SpideFx4. Goose Neck Snare
catheters5. VisiPro Balloon
Expandable Biliary Stent System
6. NanoCross .014 OTW PTA Dialation Catheter
7. EverCross .035” OTW PTA Dialation catheter
31-51-MD/2006-DC (Re-Reg. 2011)
MD-51 31-03-2014
92. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk,
M/s. ev3 Inc, 4600 Nathan Lane North, Plymouth, MN 55442, USA having factory premises at M/s. Micro Therapeutics Inc, d/b/a
SilverHawk Peripheral Plaque Excision
31-624-MD/2009-DC (Re-Reg. 2011)
MD-624 31-03-2014
22
Chennai-600010 ev3 Neurovascular Inc, 9775 Toledo Way, Irvine, CA 92618, USA
93. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi
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 790-834, Republic of Korea
SoundStar 3D Diagnostic Ultrasound Catheter
31-898-MD/2010-Dc MD-898 14-04-2014
94. M/s. Abbott Medical Optics Private Limited, No. 91, G N T Road, Madhavraman, Chennai-600110
M/s. Abbott Medical Optics Inc, 1700 E. St. Andrew Place Santa Ana, California 92705, USA having factory premises at M/s. AMO Groningen BV, Van Swietenlaan 5, 9728 NX Groningen, The Netherlands
Tecnis Multifocal 1-Piece Intraocular Lens (Model: ZMB00)
31-17-MD/2006-DC (Re-reg.) End 01
MD-17 31-05-2013
95. M/s. Cure Surgicals, S-12, 1st Floor, Green park Extension, Opp. Uphaar Cinema, New Delhi-110016
M/s. Biosomposites Limited, Keele Science Park, Keele Newcastle Under Lyme, Staffordshire, STS 5 NL, England
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
31-402-MD/2007-DC (Re-reg. 2011)
MD-402 30-06-2014
23
filler/Bone Graft Substitute
96. M/s. Clairvoyance Consulting, Flat No. 801, 8th Floor, Indra Prakash Building, 21, Barakhamba Road, Connaught Place, New Delhi-110001
M/s. Invatec Technology Centre GmbH, Hungerbuelstrasse 12a, 8500 Frauenfeld, Switzerland
IN.PACT Falcon (Rx & OTW)-Paclitaxel-eluting Balloon Dilatation PTCA Catheter
31-833-MD/2010-Dc MD-833 31-03-2014
97. M/s. Cure Surgicals, S-12, 1st Floor, Green park Extension, New Delhi-110016
M/s. Synergie Ingenierie Medicals-S.A.R.L., Z.A. de L’Angle 19370 Chamberet-France
1. Bio Fix Spacer2. Bio Fix (VTP, 3, 3G, 1, 1G,
PR, PR3G & Carnioplasty)
31-666-MD/2009-DC MD-666 14-04-2014
98. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
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
1. Ticron2. Polysorb Lactometer3. Steel 316L Stainless Steel
Suture4. Flexon temporary Cardiac
Pacing Lead
31-948-MD/2011-DC MD-948 14-04-2014
99. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Covidien 60, Middletown, Avenue, North Haven, CT 06473, USA
Total 9 products 31-949-MD/2011-DC MD-949 14-04-2014
100. M/s. Abbott Healthcare Private Limited, 4, Corporate Park, Sion Trombay Road, Chembur, Mumbai-400071
M/s. Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA having factory premises at M/s. Abbott Vascular,
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
24
26531 Yenz Road, Temecula, California 92591, USA
101. M/s. Abbott Healthcare Private Limited, 4, Corporate Park, Sion Trombay Road, Chembur, Mumbai-400071
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
Absolute PRO peripheral Self-Expanding Stent System Family
31-256A-MD/2006-DC (Re-Reg. 2010) (End 01)
MD-256A 30-04-2013
102. M/s. Hansraj Nayyar Medical, 1416 Maker Chambers V, 14th Floor, Nariman Point, Mumbai-400021
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
Epidural Catheter 31-830-MD/2010-DC MD-830 14-04-2014
103. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi
M/s. Ethicon sarl, Puits Godet 20, 2000 Neuchatel, Switzerland
1. Gynecare TVT Exact Continence System
2. Gynecare TVT ABBREVO Continence System
3. Gynecare PROSIMA Pelvic Floor Repair System
31-845-MD/2010-DC MD-845 31-04-2014
104. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi
M/s. Mentor Medical Systems B.V., Zernikedreef 2, 2333 CL Leiden, The Netherlands
1. Gel Breast Implant-Cohesive I, II, III Smooth/Siltex./CPG
2. Becker Expanders/Breast Implants
3. Spectra Adjustable Gel Breast Implants
31-884-MD/2010-DC MD-884 30-04-2014
105 M/s. India Medtronic M/s. Medtronic Inc, Resolute Integrity Zotarolimus 3164-MD/2006-DC MD-64 31-07-2012
25
Private Limited, 1241, Solitaire Corporate Park, Building No. 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093
710 Medtronic Park Way, NE Minneapolis, MN-55432, USA having factory premises at M/s. Medtronic Ireland Parkmore Business Park West, Galway, Ireland
Eluting Coronary Stent System (Re-Reg. 2009) End 08
106 M/s. Boston Scientific International BV, C-40, Okhla Industrial Area, Phase-II, New Delhi-110020
M/s. Boston Scientific Corporation, One Boston Scientific Place, Natick Massachusetts 01760-1537, USA having factory premises at M/s. Boston Scientific Cork Limited, Business & Technology Park, Model Farm Road, Cork, Ireland
1. Neuroform EZ Stent Delivery System
2. Neuro Renegade Hi-Flo Microcatheter
31-163-MD/2006-DC (Re-Reg. 2009) (End 01)
MD-163 31-03-2013
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
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
CPCS Hip[ System 31-858-MD/2010-Dc MD-858 14-04-2013
108 M/s. Avana Medical Devices Private Limited, 2nd Floor, N6D.O. 14.D, Viswanathan Street, West Mambalam, Chennai-600033
M/s. Arthrex Inc, 1370 Creekside Boulevard, Naples, Florida, USA 34108-1945
Total 4 drugs 31-846-MD/2010-DC MD-846 14-04-2014
109 M/s. Teleflex Medial M/s. Arrow 1. Central Venous Catheter 31-842-MD/2010-DC MD-=842 14-04-2014
26
private Limited, Old No. 19, 1st Floor, & Ground Floor, Harrington Road, Chetpet, Chennai-600031
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
2. Arterial Catheters and Accessories, Sterile
3. Percutaneous Sheath Introducers and accessories sterile
4. Spring wire guide and accessories, sterile
110 M/s. Biotronik Medical devices India Private Limited, 101-106, Plot No. 14, LSC, Kalkaji, New Delhi-110019
M/s. Biotronik AG, Ackerstasse 6, 8180 Bulach, Switzerland
Total 8 drugs 31-461-MD/2008-DC (Re-Reg. 2010)
MD-461 30-04-2014
111. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi
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
Total 13 drugs 31-798(A)-MD/2010-DC
MD-798(A)
30-04-2014
112. M/s. 3M India Limited, Plot Nos 48-51, Electronic City, Hosur Road, Bangalore-560100
M/s. 3M Healthcare Care, St. paul, MN 55144-1000, USA having factory premises at M/s. 3M Deutschland GmbH/Medical
1. 3M Tegaderm IV Transparent Film Dressing with Border
2. 3M Tegaderm IV Transparent Film Dressing with Frame Style
31-710 (C )-MD/2009-DC
MD-710 (C )
30-04-2014
27
manufacturing Kamen, Edisonstrasse 6, Kamen, Germany 59157
113. M/s. Covidien Healthcare India Private Limited, Doshi Towers, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
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
Helical Fasteners 31-796-MD/2010-DC (Re-Reg. 2011)
MD-796 30-04-2014
114. M/s. Covidien Healthcare India Private Limited, Doshi Towers, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. Tyco Healthcare Ireland Limited, Sragh Industrial Estate, Tullamore County, Ofally, Republic of Irlenad
1. Trocar Catheters2. Thoracic Catheters
31-46-MD/2006-DC (Re-Reg. 2011)
MD-46 30-04-2014
115. M/s. Teleflex Medial private Limited, Old No. 19, 1st Floor, & Ground Floor, Harrington Road, Chetpet, Chennai-600031
M/s. Willy Rusch GmbH, Willy-Rusch-Strasse 4-10, 71394, Kernen, Germany
RUSCH, ENDO TRACHEAL TUBES 31-776-MD/2010-DC (End 01)
MD-776 28-02-2014
116. M/s. becton Dickinson India private Limited, 5th Floor, Signature Towers, II, South City 1, Gurgaon-122001
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
1. BD Blunt Fill Needles2. BD Blunt Fill Needles with
Filter
31-669 (B)-MD/2009-DC (End 01)
MD-699(B)
14-01-2013
28
117. M/s. Globe Biomedicals, Room C/2, Juhu Apartment, Near S.N.D.T. College , Juhu, Mumbai 400049, Maharashtra
M/s. Dongguan Kewei Medical Instruments Co. Limited, Shijing Industrial Zone, Tongsha Technology Park, Dongcheng District, Dongguan City, Guangdong Province, China
1. Amender ASD Occluders2. Amender PDA Occluders3. Amender VSD Occluders
31-821-MD/2010-DC MD-821 14-05-2014
118. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. Micro Therapeutics Inc, d/b/a ev3 Neurovascular, 9775 Toledo Way, Irvine, CA 92618, USA
Total 12 Drugs 31-51A-MD/2006-DC (Re-Reg. 2011)
MD-51A 14-05-2014
119. M/s. becton Dickinson India Private Limited, No. 34, Assisi Nagar, West Thottam, Madhavaram, Chennai-51
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 00777-4010, USA
1. Kit VECSE 27G Whitacre/ 18G Weiss
2. Kit Perisafe 18G x 3/12” Weiss
31-819-MD/2010-DC MD-819 14-05-2014
120. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048, USA
1. Palindrome H Chronic Catheter Kit
2. Palindrome SI Chronic Catheter Kit
3. Palindrome HIS Chronic Catheter Kit
31-50-MD/2006-DC (Re-Reg. 2010) End 01
MD-50 31-03-2014
121. M/s. Smart Ortho Devices Private Limited, #3, Park View-I, Sohna Road, Gurgaon
M/s. ABS Corporation Inc, 5909 Baker Road, Suite 550, Minnetonka, MN 55345, USA
OrthoGlide Medical Knee Implant 31-902-MD/2011-DC MD-920 14-05-2014
29
122. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. Mediquip Sdn. Bhd, PO Box 25, 01700 Kangar, Perlis, Malaysia
Kendall Curity Latex Foley Catheter (Indwelling Urinary Catheter)
31-333-MD/2007-DC (Re-Reg. 2011)
MD-333 31-05-2014
123. 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 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
1. PEEK Prevail Cervical Interbody Device
2. CLYDESDALE Spinal System
31-69A-MD/2006-DC (Re-Reg. 2009) End 01
MD-69A 14-03-2014
124. 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 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
Mastergraft Granules 31-69A-MD/2006-DC (Re-Reg. 2009) End 02
MD-69A 14-03-2014
125. M/s. KOB Medical textiles Private Limited, 9. Manirajanna Gardens, D. No. 1996-C, Trichy Road, Singanallur, Coimbatore-641005
M/s. Karl Otto Braun GmbH & Co., KG, Lauterstrasse 50, 67752, Wolfstein, Germany
1. Kobra Cast-Thermoplastic Cast Bandage
2. Rinkilastic Cohesive-Cohesive Elastic Bandage
3. Rapidelast Color-Cohesive Elastic bandage
31-920-MD/2011-DC MD-920 31-05-2014
126. M/s. St. Jude medical India private Limited, A & B, 2nd Floor, “Brij Tarang”, Greenlands,
M/s. Light Lab Imaging Inc, One technology Park Drive, Westford, MA 01886, USA
C7 Dragonfly Imaging Catheter 31-896-MD/2010-DC MD-896 31-05-2014
30
Begumpet, Hyderabad-500016
127. M/s. Bioaide technologies Private Limited, 207, Savitri Cinema Complex, Greater kailash II, New Delhi
M/s. Lohmann and Rauscher International GmbH & Co., Kg, Westerwaldstrasse 4. 56579 Rengsdorf, Germany
1. Curapor (Sterile Island Dressing)
2. VIiwazell (Sterile Dressing Pad)
3. Metalline (Sterile Dressing Pad)
4. Raucodrape Surgical Incise Drape
31-490-MD/2008-DC (Re-Reg. 2011)
MD-490 30-06-2014
128. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi
M/s. Ethicon Sarl, Puits Godet 20, 2000 Neuchatel, Switzerland
Total 6 drugs 31-845-MD/2010-DC (End 01)
MD-845 30-04-2014
129. M/s. DePuy medical private Limited, Plot no. 4, Survey No. 277/4, Demni Road, Village-Dadra-Dadra & Nagar haveli (U.T.)
M/s. DePuy International Limited, trading as M/s. DePuy CMW, Cornford Road, Blackpool, FY4 4QQ, England UK
Total 7 drugs 31-915-MD/2011-DC MD-915 31-05-2014
130. M/s. Terumo Corporation, Chennai Branch, Alexander Square, 34 & 35, 4th Floor, Sardar Patel Road, Guindy, Chennai-600032
M/s. Vascutek limited, A Terumo Company, Newmains Avenue, Inchinnan, Renfrewshire, PA4 9RR, Scotland
Total 6 drugs 31-880-MD/2010-Dc MD-880 14-06-2014
131. M/s. Spinemed Systems, LG-1, Pankaj Market, Behind Natraj Vihar Society, I.P. Extn. Patparganj, Delhi-110092
M/s. Orthofix Inc, 3451, Plano Parkway, Lewisville, Tx 75056
1. Spinal Fixation System2. Ascent TM POCT System3. Firebird Spinal Fixation
System4. 3 Deg Anterior Cervical
Plate System5. Pillar Peek Spacer System6. Construx Peek Partial
VBR System
31-976-MD/2011-DC MD-976 31-05-2014
31
132. M/s. Hester Diagnostics Private Limited, Room No. 9, 1st Floor, 66, princess Street, Mumbai-400002
M/s. Penumbra Inc, 1351, Harbor Bay, Parkway, Alameda, CA 94502, USA
Penumbra System consisting of:1. Penumbra Reperfusion
Catheter 2. Penumbra Separator3. Penumbra Aspiration
Tubing4. Neuron delivery Catheter5. Neuron Select Catheter
31-499-MD/2008-DC (Re-Reg. 2011)
MD-499 30-09-2014
133. 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. Smith & Nephew Medical Limited, 101 Hessle Road, Hull, HU3 2BN, UK
Acticoat/Acticoat7 31-969 (FF-159)-MD/2011-DC
MD-969 (FF-159)
30-04-2012
134. M/s. St. Jude medical India private Limited, A & B, 2nd Floor, “Brij Tarang”, Greenlands, Begumpet, Hyderabad-500016
M/s. St. Jude Medical System AB, Palmbladsgatan 10, Box 6350 SE 75135 Uppsala, Sweden
1. PressureWire Aeris Including PressureWire Receiver
2. PressureWire Certus
31-727-MD/2009-DC MD-727 14-07-2014
135. M/s. DePuy Medical Private Limited, 64-66 Senapati Bapat Marg, Mahim, Mumbai-400016
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
Moss Miami Spinal System (Non-Sterile)
31-288-MD/2006-DC (Re-Reg. 2010) End 01
MD-288 14-06-2013
136. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
M/s. Clearstream Technologies Limited, Moyne Upper, Enniscorthy Co.
Sleek PTW PTA balloon Catheter (Sterile)
31-239-MD/2006-D (Re-Reg. 2009) (End 01)
MD-239 31-12-2012
32
Wexford, Ireland137. M/s. Abbott Healthcare
Private Limited, 4, Corporate Park, Sion Trombay Road, Mumbai-400071
M/s. Abbott Laboratories, Abbott Vascular Inc, 400 Saginaw Drive, redwood City, California 94063, USA
1. Prostar XL Percutaneous Vascular Surgical System and Accessories
2. Perclose ProGlide Suture-Medicated Closure System and Accessories
31-867-MD/2010-DC MD-867 30-06-2014
138. M/s. Johnson and Johnson Limited, J-1 Shree Arihant Complex, Vill Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi
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
Biopatch Antimicrobial Dressing with Chlorhexidine Gluconate
31-815(B) (FF-325)-MD/2008-DC (Re-Reg. 2010)
MD-815(B)
14-07-2014
139. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
M/s. VNUS medical technologies Inc, 5799 Fontanoso Way, San Jose CA 95138, USA
Catheter (Closure Fast Closure RFS)
31-789-MD/2010-DC MD-789 14-07-2014
140. M/s. Zimmer India Private Limited, Plot No. B & B1, vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016
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
141. M/s. becton Dickinson India Private Limited, No. 34 Assisi Nagar, West Thottam,
M/s. Becton Dickinson Infusion Therapy AB, Gasebacksvagen 36, PO Box 631, 251 06
BD Connecta 31-911-MD/2011-DC MD-911 30-06-2014
33
Madhavaram,. Chennai-51
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
142. M/s. Biomet Orthopaedic India Private Limited, 2301, Shanti Esate, Ghansham Estate, National Highway No. 8, Aslali, Tal: Daskroi (NA)
M/s. Biomet 3i, 4555 Riverside Drive, palm beach Gardens, Florida 33410, USA
Dental Implant System 31-900-MD/2010-DC MD-900 30-06-2014
143. M/s. Exactech India Private Limited, No. 21, ‘F’ Block, 2nd Floor, Annanagar east, Chennai-600102
M/s. Exactech Inc, 2320, 2243, 2402 & 2411, NW 66th Court, Gainesville, Florida 32653, USA
1. Total Hip Replacement System-cemented
2. Total Hip Replacement System-Cementless
3. Total Knee Replacement System
4. Exactech Equinoxe Shoulder System
31-503-MD/2008-DC (Re-Reg. 2011)
MD-503 31-07-2014
144. M/s. Biotronik medical devices India Private Limited, 101-106, Plot No. 14, LSC, Kalkaji, New Delhi-110019
M/s. Biotronik AG, Ackerstasse 6, 8180 Bulach, Switzerland
Pantera Lux Paclitaxel Releasing PTCA Balloon Catheter
31-461-MD/2006-DC (Re-Reg. 2010) End 01
MD-461 30-04-2014
145. M/s. Cosmotec Medicaments Private Limited, No. 2, 1st Floor, HR-8, Balaji Complex, Sharma Market, Pulpehladpur,
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
34
New delhi-110044146. M/s. Baxter India
private Limited, 2nd Floor, Towe C, Building 8, DLF Cyber City, Phase-II, Gurgaon-122002
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
147. M/s. Vascular Solutions India private Limited, Building No. H-142, 1st Floor, Rajlaxmi Commercial Complex, Kalher, Thane-Bhiwandi Road, Bhiwandi-421302
M/s. Clearstream Technologies Moyne Upper, Enniscorthy, Co. Waxford, Ireland
1. Nimbus Salvo PTCA Catheters
2. EzeCTO PTCA Catheters3. EzeCTO-RX PTCA
Catheters4. FlexeCTO PTCA Catheters
31-231-MD/2006-DC (Re-Reg. 2010) End 01
MD-231 14-06-2013
148. M/s. Zimmer India Private Limited, Plot No. B & B1, Vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016
M/s. Zimmer GmbH, Sulzer Allee 8, CH-8404 Winterthur, Switzerland
1. Ceramic Femoral Head2. Metal (CoCr) Femoral
Head3. Metasul Head
31-171-MD/2006-DC (Re-reg. 2009)End 05
MD-171 31-07-2012
149. M/s. Clairvoyance Consulting, Flat No. 801, 8th Floor, Indra Prakash Building, 21 Barakhamba Road, Connaught Place, New Delhi-110001
M/s. Invatec Technology centre GmbH, Hungerbuelstrasse 12a, 8500 Frauenfeld, Switzerland
Maris Plus-Peripheral Self-Expanding Stent System
31-833-MD/2010-DC (End 02)
MD-833 31-03-2014
150. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, District-Thane, Bhiwandi
M/s. Ethicon Inc, Route 22 West, Somerville, New Jersy 08876-0151, USA having factory premises at M/s. Ethicon Inc, 5250 Greens Dairy Road, Raleigh, North Carolina 27616, USA
Ethicon OMNEX Surgical Sealant 31-899-MD/2010-DC MD-899 30-06-2014
35
151. M/s. DePuy Medical private Limited, 64-66, Senapati Bapat Marg, Mahim, Mumbai-400016
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
1. Uniplate 2 Anterior Cervical Plate System
2. Expedium Spine System-Peek Rod
31-288-MD/2006-DC (Re-Reg. 2010) End 02
MD-288 14-06-2013
152. M/s. Atlantic Pharmaceuticals, 101, Business Point 349, Western Express Highway, Andheri (E), Mumbai-400069
M/s. Joline GmbH & Co. KG Neue Rottenbunger Str, 50-D-72379 Hechingen
1. Double Lumen ST Catheter Kit
2. Double Lumen LT Catheter Kit
31-243-MD/2006-DC (Re-Reg. 2010)
MD-243 14-07-2014
153. M/s. Anand mediproducts Private Limited, 16, Road No. 33, Punjabi Bagh Extn, New Delhi-110026
M/s. Degradable Solutions AG, Wagistrasse 23 CH-8952 Schieren, Switzerland
Easy Graft/Crystal 31-870-MD/2010-Dc MD-870 31-07-2014
154. M/s. Globe Bio-Medical, C/2 Juhu Apartments, Near S.N.D.T. College, Juhu, Mumbai-4000049
M/s. Alco-advanced Lighweight construction GmbH, Teplitzer str, 5-D, 14193, Berlin, Germany
1. Alis CR L 605 Rapamycin Eluting Coronary Stent
2. Alis 20 Coronary Stent3. Alex-R Rapamycin Eluting
PTCA Catheter4. Alex Coronary Dilation
Catheter
31-04-MD/2006-DC (Re-reg. 2009)
MD-04 30-06-2012
155. M/s. Amardeep Enterprises, No. 5-6, 3rd Floor, Nr. Income Tax Building, Ashram Road, Ahmedabad-380009
M/s. Solco Bio-Medical Co. Limited, 34-6, Keumam-ri, Seotan-myeon Pyengtack, Gyeonggi-do, 451-852, The Republic of Korea
4CIS Solar Spine System (Non-Sterile)
31-383-MD/2007-DC (Re-Reg. 2011)
MD-383 31-07-2014
156. M/s. St. Jude Medical India Private Limited, A & B, 2nd Floor, Brij
M/s. St. Jude medical cardiac Rhythm Management Division
Total 7 drugs 31-300-MD/2007-DC (Re-Reg. 2010) End 01
MD-300 14-09-2013
36
Tarang, Greenland, Begumpet, Hyderabad-500016
15900 Valley View Court Sylmar 91342, USA
157. M/s. metro Biosol Private Limited, 26 Hauz khas Vill, New Delhi-110016
M/s. VEXIM SAS, 75, rue Saint Jean, 31130, Balma, France
Spine Jack System1. Preparation Kit2. Expansion Kit3. Cohesion Bone Cement
31-924-MD/2011-DC MD-924 31-07-2014
158. 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, West Galway, Ireland
Valiant Thoracic Stent Graft with the Captivia delivery System
31-64-MD/2006-DC (Re-Reg. 2009) End 09
MD-64 31-07-2012
159. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
M/s. Johnson & Johnson International, C/o European Logistics centre Lenneke Marelann 6, BE-1932 St Stevens Woluwe, Belgium having factory premises at M/s. Johnson & Johnson Medical GmbH, Robert Koch Srasse 1, D-22851 Norderstedt, germany
Physiomesh 31-816(FF-319)-MD/2008-DC (Re-Reg. 2011) End 01
MD-816 (FF-319)
14-02-2014
160. M/s. Apothecaries Private Limited, 579, devil, East of Sainik Farms, New Delhi-110062
M/s. Hoya Corporation, 2-7-5 Naka-Ochiai, Shinjuku-Ku, Tokyo 161-8525, Japan having factory premises at M/s. Hoya Medical Singapore Pte Limited, 455A, Jalan
Hoya AF-1iMics1 NY-60 31-701-MD/2009-DC (End 01)
MD-701 30-11-2012
37
Ahmad Ibrahim 639939, Singapore
161. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
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
Webster CS Catheter 31-119-MD/2006-DC (re-reg. 2009) End 01
MD-119 31-05-2013
162. M/s. fenwal India private Limited, Khasra # 1220, 1st & 2nd Floor, Village Ritahla, Delhi-110085
M/s. Fenwal Inc, Three Corporate Drive, lake Zurich IIlinois 60047, USA having factory premise at M/s. Fenwal International Inc, Camino Real Industrial park, Road # 122, San German, Puerto Rico 00683, USA
1. Amicus Apheresis Kit2. Closed System Apheresis
Kit3. Open System Apheresis
Kit
31-963-MD/2011-DC MD-963 31-07-2014
163. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036
M/s. Ethicon Inc, Route 22 West, Somerville, New Jersy 08876-0151, USA
1. Prolene Soft Mesh2. Gynecare Gynemesh PS3. Vicryl Mesh
31-906 (FF-132)-MD/2011-DC (end 01)
FF-132 28-02-2012
164. M/s. Cure Surgicals, Shop No. 4, G.F. Green Park Extn, New Delhi
M/s. GS Medical Co. Limited, 12-F, Kolon Digital Twoer Aston, 505-14, Gasan-dong, Geumcheon-gu, seoul, 153-803, Korea having factory premises at M/s. GS Medical Co. Limited, #636, Yeonje-ri, Gangoe-myeon,
GSS Pedicle Screw System 31-945-MD/2011-DC MD-945 31-07-2014
38
Cheongwon-gun, Chungbuk, Korea
165. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010
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
Surgipro II Monofilament Polypropylene Suture
31-796-MD/2010-DC (Re-Reg. 2011) End 01
MD-796 30-04-2014
166. M/s. Boston Scientific International BV, 100A, The Capital Court, Olof Plame Marg, Munirka, New Delhi-110067
M/s. Boston Scientific Corporation One Boston Scientific Place, Natick MA 01760-1537, USA having factory premises at M/s. Boston Scientific Corporation, Two Scimed Place Maple Grove, MN 55311-1566, USA
1. Apex Over-The-Wire PTCA Dilatation catheter
2. Maverick2 Monorail PTCA Dilatation Catheter
3. Express Vascular SD Premounted Stent System
4. Gateway PTA Balloon Catheter
31-857-MD/2010-DC MD-857 31-07-2014
167. M/s. Surgimed, D-22 Okhla Industrial Area, Phase-I, New Delhi-110020
M/s. Vascular Solutions Inc, 6464 Sycamore Court, Minneapolis, Minnesota 55369, USA
GuideLiner Catheter 31-202-MD/2006-DC (Re-reg. 2010) End 01
MD-202 14-09-2013
168. M/s. Zimmer India Private Limited, Plot No. B & B1, Vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016
M/s. Zimmer Spine Inc, 5301 Riata Park Court, Building F, Austin, Tx 78727, USA
Sequoia Pedical e Screw System 31-864-MD/2010-DC MD-864 31-07-2014
169. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-
M/s. Acclarent Inc, 1525-B O’Brien Drive, Menlo Park, CA 94025
1. Relieva Solo Pro Sinus Balloon Catheter (with or without stylet)
2. Relieva Flex Sinus Guide
31-890-MD/2010-DC MD-890 31-07-2014
39
Bhiwandi Road, District-Thane, Bhiwandi
Catheter3. Relieva Vortex Sinus
Catheter4. Inspira Air Balloon
Dilation System170. M/s. Zimmer India
Private Limited, Plot No. B & B1, Vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016
M/s. Zimmer GmbH, Sulzer Allee 8, CH 8404, Winterthur, Switzerland
NCB Polyaxial Locking Plate System
31-171-MD/2006-DC (Re-Reg. 2009) End 02
MD-171 31-07-2012
171. M/s. Teleflex Medical private Limited, Old No. 10, No. 19, 1st Floor, Ground Floor, Harrington Road, Chetpet, Chennai-600031
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
Tracheal Tube (Teleflex ISIS Tracheal Tubes-Catalogue#112662)
31-851-MD/2010-DC MD-851 31-07-2014
172. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, District-Thane, Bhiwandi
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
Prevelle Silk Dermal Filler 31-879-MD/2010-DC MD-879 31-07-2014
173. M/s. Mn Solutions, Shop No. 26-27, 2nd Floor, Prop. No. WZ-26, Nangli Jalib Village,
M/s. Arthrocare Corporation, 680 Vagueros Avenue, Sunnyvale, CA 94085,
1. Opus Anchor Sutures-Rotator Cuff Repairs
2. Opus Anchor Sutures for Labral Repair
31-774-MD/2010-DC MD-774 31-07-2014
40
Janak Puri, New Delhi-110058
USA having factory premises at M/s. Arthrocare Costa Rica 502, Global Parkway, Global Park, la Aurora Heredia, Costa Rica
174. M/s. B L Lifesciences Private Limited, a-245, Okhla Industrial Area, Phase-I, New Delhi-110020
M/s. Kinamed Incorporated, 820 Flynn Road, Camarillo, California 93012-8701, USA
NeuroPro the complete Neurosurgical Rigid Fixation System (Non-Sterile)
31-237-MD/2010-DC (Re-Reg. 2010)
MD-237 31-07-2014
41