FDA Registration
Active
🇩🇪 Germany
ROSE GMBH FUER MEDIZINTECHNIK
Reg #: 3002808022
·
FEI: 3002808022
·
Expires 2025
Products
2
Proprietary Names
0
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- ROSE GMBH FUER MEDIZINTECHNIK
- Registration Number
- 3002808022
- FEI Number
- 3002808022
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gottbillstrasse 25
- City
- Trier Rhineland-Palatinate
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K180263
Owner / Operator
- Firm Name
- Rose GmbH fuer Medizintechnik
- Operator Number
- 10042910
- Address
- Gottbillstrasse 25
- City
- Trier
- State
- Rhineland-Palatinate
- Postal Code
- 54294
- Country
- DE
- Correspondent
- Thomas Rose
US Agent
- Business Name
- German American Chamber of Commerce, Inc.
- Contact Name
- German American Chamber of Commerce, Inc. German American Ch
- Address
- 80 Pine Street, 24th Floor
- City
- New York
- State
- NY
- ZIP
- 10005
- Country
- US
- [email protected]
- Phone
- 212 9748830
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 | 2018-10-30 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2018-10-30 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)