BEUDAMED
    FDA Registration Active 🇫🇷 France

    Sandman Auto without Humidifier

    Reg #: 3013620584 · FEI: 3013620584 · Expires 2025
    View on FDA
    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
    2025
    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
    SLEEPRES, LLC
    Contact Name
    Craig Salazar
    Address
    1508 Carl Adams Dr Ste 200
    City
    Murfreesboro
    State
    TN
    ZIP
    37129
    Country
    US
    Email
    [email protected]
    Phone
    615 9212406

    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