FDA Registration
Active
🇩🇪 Germany
DOT GMBH
Reg #: 3006001176
·
FEI: 3006001176
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DOT GMBH
- Registration Number
- 3006001176
- FEI Number
- 3006001176
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Charles-Darwin-Ring 1a
- City
- Rostock Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K093433
Owner / Operator
- Firm Name
- DOT GmbH
- Operator Number
- 10037690
- Address
- Charles-Darwin-Ring 1a
- City
- Rostock
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 18059
- Country
- DE
- Correspondent
- Katrin Wenke
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 |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-18 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)