Registration Certificates issued for the Medical Devices along with their Manufacturing sites and Indian Authorized
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1 Registration Certificates issued for the Medical Devices along with their Manufacturing sites and Indian Authorized Agents from December 2016 to till Date S.No. Name of Indian Agent 1. M/s. Kalyx India Healthcare Pvt. Ltd.,Old no. 12, New No. 20, 1 st Floor, M-Block, 8 th Street, Anna Nagar (East), Chennai M/s. Covidien Healthcare India Pvt. Ltd., # 156, Doshi Towers, 6 th Floor, Poonamallee High Road, Kilpauk, Chennai M/s. Osstem Implant India Pvt. Name of Manufacturer Name of the Device File No. R. C. No. M/s. Dieter Marquardt Medizintechnik GmbH., site at Robert-Bosch-Str. 1, D Spaichingen- Germany and its medical device M/s. Covidien LLC, 15 Hampshire Street, Mansfield, MA USA having at M/s. Covidien Manufacturing solutions, S.A., Edificio B20, Calle #2 Zona Franca, Coyol, Alajuela, Costa Rica M/s. Osstem Implant Co. Ltd., having 1. Orthopaedic Trauma Implants (Screws)- Non-sterile (Titanium) 2. Ortholpaedic Trauma Implants (Plates)- Non-sterile (Titanium) 3. Orthopaedic Trauma Implants (Screws)- Non-Sterile (Stainless Steel) 4. Orthopaedic Trauma Implants (Plates)- Non-sterile (Stainless Steel) 5. Plates & Screws (Hip)- Nonsterile (Stainless steel) 6. Orthopaedic Trauma Implants- Intramedullary Implants (Screws)-sterile (Titanium) 7. Orthopaedic Trauma Implants- Intramedullary Implants (Nails)- sterile (Trauma) 1. Mahurkar Elite Acute Dual Lumen Catheter Kits, Catheter 2. Mahurkar Elite Acute Triple Lumen Catheter Kits, Catheter Titanium Mesh (Barrier, Intra-Oral, Nonabsorbable for tissue regeneration) MD/2012-DC(Re. Reg.01) (End. 01) Date of Issue Validity of the Registration Certificate to To
2 Ltd., Office No. 306, 3 rd Floor, A Wing, Sagar Tech Plaza Sakinaka, Andheri- Kurla Road, Andheri (E), Mumbai M/s Nipro India Corporation Private Ltd., New No. 167, Old No. 131, Yes dee House, 1st Floor, Valluvar kottam High Road, Nungambakkam, Chennai at 66-16, Bansong-ro 513 Beon-gil, Haeundae-gu, Busan, Korea. M/s. Nipro Corporation, 3-9-3, Honjo Nishi Kita -Ku, Osaka , Japan premises at M/s. Nipro Medical Industries ltd., , Matsubara, Tatebayashi- Shi, Gumna: Japan (End. 01) Nipro Spinal Needle, Spinal Needle MD/2012-DC (Re. Reg. 01) (End. 01) M/s. Terumo India Pvt. Ltd., 117/3D & 117/3C (Part 1-C), Padmavathi Gardens, Numbal, Velapanchavadai, Post, Thiruverkadu, Chennai M/s. Stryker India Pvt. Ltd., Khewat No. 122, Kahta No. 157, Mustakil No. 98, Kila No. 6, 7, 8/1, 13/1 Village Bhondsi, District M/s. Terumo (Philippines) Corporation, # 124 East Main Avenue, Laguna Tecnopark, Binan, Laguna, Philippines premises at M/s. Terumo (Philippines) Corporation, # 124 East Main Avenue, Laguna Tecnopark, Binan, Laguna, Philippines M/s. Howmedica Osteonics Corporation, 325 Corporate Drive Mahwah, New Jersey 07430, USA Having manufacturing premises at 1. Surguart2 safety Hypodermic Needle, Hypodermic Needle 2. Surguart3 safety Hypodermic Needle, Hypodermic Needle Modular Dual Mobility Insert (MDMCoCrLiner), Hip replacement implant component- Liner MD/2014-DC MD/2006- DC(Re. Reg.03) End to
3 Gurgaon, Haryana M/s. Stryker Ireland Ltd., IDA Industrial Estate, Carrigtwohill Co., Cork, Ireland 7. M/s. Cambridge Medical India Pvt. Ltd., First Floor, F- 2, New No. 108, old no. 3, 86 th Street, 18 th Avenue, Ashok Nagar, Chennai , Tamil Nadu, India 8. M/s. Merit Medicals Systems India Pvt. Ltd., Unit No, , H.M. Geneva House 2 nd Floor, No. 14, Cunningham Road Bangalore M/s. Zimmer India Pvt. Ltd., 14th Floor, Tower-5B DLF Cyber Terraces, DLF Cyber City, Gurgaon , Haryana, India 10. M/s. Vardhman Medicare Pvt. Ltd. L-90/164, 2 nd Floor, Street No. 7, M/s. Bioplate, Inc., premises at 3643 Lenawee Avenue, Los Angeles, California USA M/s. Merit Medical Systems Inc., 1600 West Merit Parkway, South Jordan, Utah 84095, USA premises at M/s. BioSphere Medical, S.A. Pare des Nations- Paris Nord 2, 383 rue de la Belle Etoile, Roissy EN France M/s. Zimmer Inc., having at 1800 West Center Street, Warsaw Indiana 46580, USA M/s. Rocket Medical Plc., premises at 2-4 Sedling Road, wear Industrial 1. Plates, Screws, Bio Mesh, Maxillofacial System- Titanium (Non Sterile) 2. Plates, Screws, Bio Mesh, ZIP Implants, Neurosurgery Cranial Fixation System- Titanium (Non Sterile) Bearing nspva Embolization particles, Embolic Microspheres (Non spherical polyviny1 Alcohol) Persona the Personalized knee System Stem Extension, Stem Extension 1. Rocket IPC, Rocket IPC Insertion Set 2. Rocket, Rocket Thoracentesis Catheter MD/2013-DC MD/2006- DC (End. 01) MD/2014-DC to to to
4 Mahipalpur Extn, New Delhi Estate, Washington, Tyne and Wear, NE38 9BZ, United Kingdom 3. Rocket, Rocket Multipurpose Needle 4. Rocket, Rocket Thoracic Catheter 5. Rocket, Rocket Disposable Ultrasound Needle Guide 6. Rocket, Rocket Seldinger Chest Catheter Drainage Kit 7. Rocket, RocketBlunt dissection chest drainage insertion pack 8. Rocket, Rocket HSG Sonohystogram Catheter 9. Rocket, Rocket Embryo Transfer Set 10. Rocket, Rocket Needle 11. Rocket, Rocket KCH Fetal Bladder Drainage 11. M/s. Epsilon Eye Care Pvt. Ltd., Ground Floor 49, Palihil-3, Tithal Road, Valsad, Taluka: Valsad M/s. Medennium Inc., 13 avenue de Montrouge Esc Bourg la Reine, France having at M/s. Medennium Inc., 9 Parker Suite 150, Irvice, CA USA 1. Matrix, Acrylicv /Matrix Acrylic / Aurium, 2. Matrix, Acrylicv /Matrix Acrylic / Aurium, 3. Medennium Phakic Lens, MD/2016- DC to
5 12. M/s. Covidien Healthcare India Pvt. Ltd., No. 156, Doshi Towers, 6 th Floor, Poonamallee High Road, Kilpauk, Chennai M/s. Sandor Medicaids Pvt. Ltd., D. No /5, Ground Floor, Road No. 3, Banjara Hills, MCH Circle- 10 Mandal, Hyderabad M/s. Modi Mundi pharma Pvt. Ltd., A-81 First Floor, Okhla Industrial Area Phase-II, New Delhi M/s. Venus Medical Products, 388 Sant Nagar East of Kailash, New Delhi M/s. Mirco Therapeutics, Inc. d/b/a ev3 Neurovascular, having at 9775 Toledo Way, Irvina, CA USA M/s. ULURU Inc., 4452 Beltway Drive, Addison TX, 75001, USA, having at M/s. Anteco Pharma LLC, 925 Development Drive, Lodi, Wisconsin 53555, USA M/s. Anika Therapeutics, Inc., having at 32 Wiggins Avenue, Bedford MA USA M/s. Lanstec (Barbados) Inc., having Manufacturing premises at Airport commercial center, Pilgrim Road, Christ Church BB Pipeline Flex Embolization Device, Embolization Device Altrazeal Transforming Powder Dressing, Transforming Powder Dressing Monovisc, Cross linked sodium hyaluronate 22mg/ml Softec I, Softec HD, Tetraflex HD, SBL- 3, Hydrophilic Acrylic lol (A)- MD/2016-DC (Re. Reg.03) (End.03) MD/2012-DC (Re. Reg. 01) 51 (A) to
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