FDA Registration
Active
🇫🇷 France
PRECIMADE
Reg #: 3011943495
·
FEI: 3011943495
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- PRECIMADE
- Registration Number
- 3011943495
- FEI Number
- 3011943495
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 20 av Arsene d'Arsonval
- City
- Bourg en Bresse Ain
- Country
- FR
Owner / Operator
- Firm Name
- Precimade
- Operator Number
- 10054968
- Address
- 161 Avenue Franklin Roosevelt
- City
- Decines
- State
- Auvergne-Rhone-Alpes
- Postal Code
- 69150
- Country
- FR
- Correspondent
- Marc GAGNANT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-12-07 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-12-07 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2022-12-07 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2025-04-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-02-04 |
Proprietary Names
FX V135 Shoulder Prosthesis
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)