FDA Registration
Active
🇩🇪 Germany
DRA
Reg #: 3012106319
·
FEI: 3012106319
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FMZ GMBH
- Registration Number
- 3012106319
- FEI Number
- 3012106319
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Charles-Darwin -Ring 3A
- City
- Rostock Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K231132
Owner / Operator
- Firm Name
- FMZ GmbH
- Operator Number
- 10084410
- Address
- Charles-Darwin -Ring 3A
- City
- Rostock
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 18059
- Country
- DE
- Correspondent
- Katja Quednau
US Agent
- Business Name
- Blackwell Device Consulting
- Contact Name
- Angela Blackwell
- Address
- 16409 Se Division St Ste 216
- City
- Portland
- State
- OR
- ZIP
- 97236
- Country
- US
- [email protected]
- Phone
- 704 4509934
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-03-07 |
Proprietary Names
DRA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)