FDA Registration
Active
🇩🇪 Germany
M1191T
Reg #: 9681377
·
FEI: 1000300598
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Nicolay GMBH
- Registration Number
- 9681377
- FEI Number
- 1000300598
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- GRAF-ZEPPELIN-STRASSE 21
- City
- NAGOLD Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K032979
Owner / Operator
- Firm Name
- NICOLAY GMBH
- Operator Number
- 9022544
- Address
- GRAF-ZEPPELIN-STRASSE 21, --
- City
- NAGOLD
- State
- Baden-Wurttemberg
- Postal Code
- 72202
- 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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-09-19 |
Proprietary Names
M1191T
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)