FDA Registration
Active
🇩🇪 Germany
Michael Bubolz GmbH
Reg #: 3009536102
·
FEI: 3009536102
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Michael Bubolz GmbH
- Registration Number
- 3009536102
- FEI Number
- 3009536102
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Carl-Zeiss-StraBe 42
- City
- Stuhr Lower Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K234044
Owner / Operator
- Firm Name
- Michael Bubolz GmbH
- Operator Number
- 10080837
- Address
- Carl-Zeiss-StraBe 42
- City
- Stuhr
- State
- DE-NOTA
- Postal Code
- D-28816
- Country
- DE
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-12-05 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)