FDA Registration
Active
🇫🇷 France
TEKNIMED SAS
Reg #: 9615788
·
FEI: 3003854593
·
Expires 2026
Products
14
Proprietary Names
3
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- TEKNIMED SAS
- Registration Number
- 9615788
- FEI Number
- 3003854593
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11_12 rue d Apollo
- City
- L Union Haute-Garonne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K103433
Owner / Operator
- Firm Name
- Teknimed
- Operator Number
- 9040657
- Address
- 8 rue du Corps Franc-Pommies
- City
- Vic en Bigorre
- State
- Hautes-Pyrenees
- Postal Code
- 65500
- Country
- FR
- Correspondent
- Stephanie Salles
US Agent
- Business Name
- Regulatory/Quality Management Information Source, Inc.
- Contact Name
- Barry Sands
- Address
- 110 Haverhill Rd Ste 524
- City
- Amesbury
- State
- MA
- ZIP
- 01913
- Country
- US
- [email protected]
- Phone
- 978 8345701
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2011-12-05 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2003-07-17 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2024-01-16 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2023-08-07 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2025-08-04 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2025-08-04 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2023-12-12 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-08-23 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2008-09-26 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2007-08-14 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2009-05-04 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2011-07-07 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2008-09-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-09 |
Proprietary Names
GENTAFIX (1 3 3MV)
Dynamo Spinal cement System Gun MV
Max V Cement Mixing System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device