FDA Registration
Active
🇩🇪 Germany
PURACON GMBH
Reg #: 3004638532
·
FEI: 3004638532
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PURACON GMBH
- Registration Number
- 3004638532
- FEI Number
- 3004638532
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Isarstrasse 1
- City
- Rosenheim Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K140701
Owner / Operator
- Firm Name
- puracon GmbH
- Operator Number
- 10028435
- Address
- Isarstrasse 1
- City
- Rosenheim
- State
- Bavaria
- Postal Code
- D-83026
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2018-12-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-12-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-12-18 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)