FDA Registration
Active
🇩🇪 Germany
PROMOTEC-MEDIZINTECHNIK GmbH
Reg #: 3011245468
·
FEI: 3011245468
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PROMOTEC-MEDIZINTECHNIK GmbH
- Registration Number
- 3011245468
- FEI Number
- 3011245468
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- An der Dahlewitzer Heide 11
- City
- Blankenfelde / Mahlow Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K102771
Owner / Operator
- Firm Name
- PROMOTEC-Medizintechnik GmbH
- Operator Number
- 10047598
- Address
- An der Dahlewitzer Heide 11
- City
- Blankenfelde / Mahlow
- State
- Brandenburg
- Postal Code
- 15827
- Country
- DE
- Correspondent
- Mike Horney
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2018-12-05 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)