FDA Registration
Active
🇩🇪 Germany
ARISTOTECH INDUSTRIES GMBH
Reg #: 3010206549
·
FEI: 3010206549
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ARISTOTECH INDUSTRIES GMBH
- Registration Number
- 3010206549
- FEI Number
- 3010206549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Im Biotechnologiepark
- City
- Luckenwalde Brandenburg
- Country
- DE
Owner / Operator
- Firm Name
- Aristotech Industries GmbH
- Operator Number
- 10053573
- Address
- Im Biotechnologiepark
- City
- Luckenwalde
- State
- Brandenburg
- Postal Code
- 14943
- Country
- DE
- Correspondent
- Jens-Erik Wegner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-07-16 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2024-07-16 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-07-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2024-07-16 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-07-16 |
Proprietary Names
Z1 Hip System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)