FDA Registration
Active
🇫🇷 France
SEFAM MEDICAL
Reg #: 3013620584
·
FEI: 3013620584
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEFAM MEDICAL
- Registration Number
- 3013620584
- FEI Number
- 3013620584
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10 allee Pelletier-Doisy
- City
- Villers-les-Nancy Meurthe-et-Moselle
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K080439
Owner / Operator
- Firm Name
- SeFam Medical
- Operator Number
- 10089599
- Address
- 10 allee Pelletier-Doisy
- City
- Villers-lès-Nancy
- State
- FR-NOTA
- Postal Code
- 54600
- Country
- FR
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr Ne
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2023-12-21 |
Proprietary Names
Sandman Auto without Humidifier
Model M-114801-114802-US
Establishment Types
Manufacture Medical Device