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
Phone
239 3076063

Products

Device Name Product Code
Ventilator, Non-Continuous (Respirator) BZD

Proprietary Names

Sandman Auto without Humidifier Model M-114801-114802-US

Establishment Types

Manufacture Medical Device