FDA Registration
Active
🇩🇪 Germany
4F PV Catheters
Reg #: 3008497357
·
FEI: 3008497357
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MedFact Engineering GmbH
- Registration Number
- 3008497357
- FEI Number
- 3008497357
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hammerstr. 3
- City
- Loerrach Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K031599
Owner / Operator
- Firm Name
- MEDFACT ENGINEERING GMBH
- Operator Number
- 10045544
- Address
- Hammerstrasse 3
- City
- Loerrach
- State
- Baden-Wurttemberg
- Postal Code
- 79540
- Country
- DE
- Correspondent
- JOERG REINHARDT
US Agent
- Business Name
- Graematter, Inc
- Contact Name
- Melissa Walker
- Address
- 225 W Crockett St
- City
- De Kalb
- State
- TX
- ZIP
- 75559
- Country
- US
- [email protected]
- Phone
- 636 4057498
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-04-10 |
Proprietary Names
4F PV Catheters
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)