FDA Registration
Active
🇩🇪 Germany
NanoBone QD
Reg #: 3011483489
·
FEI: 3011483489
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biocomposites GmbH (former ARTOSS GmbH)
- Registration Number
- 3011483489
- FEI Number
- 3011483489
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fischerweg 421
- City
- Rostock Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K250521
Owner / Operator
- Firm Name
- Biocomposites GmbH (former ARTOSS GmbH)
- Operator Number
- 10048987
- Address
- Fischerweg 421
- City
- Rostock
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 18069
- Country
- DE
- Correspondent
- Walter Gerike
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-05-15 |
Proprietary Names
NanoBone QD
NanoBone SBX Putty
Establishment Types
Manufacture Medical Device