FDA Registration
Active
🇩🇪 Germany
GUNTER MEDICAL GMBH
Reg #: 3016733895
·
FEI: 3016733895
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUNTER MEDICAL GMBH
- Registration Number
- 3016733895
- FEI Number
- 3016733895
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Germany, Hanauer Strasse, 8,, Hanauer Strasse,8
- City
- Pforzheim Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K220823
Owner / Operator
- Firm Name
- Gunter Medical GmbH
- Operator Number
- 10069824
- Address
- Germany, Hanauer Strasse, 8,, Hanauer Strasse,8
- City
- Pforzheim
- State
- Baden-Wurttemberg
- Postal Code
- 75181
- Country
- DE
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2022-11-21 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)