BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ENBIO GROUP AG

    Reg #: 3016777357 · FEI: 3016777357 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ENBIO GROUP AG
    Registration Number
    3016777357
    FEI Number
    3016777357
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Eichengasse 3
    City
    Oensingen Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K210279

    Owner / Operator

    Firm Name
    Enbio Group AG
    Operator Number
    10073617
    Address
    Eichengasse 3
    City
    Oensingen
    State
    Solothurn
    Postal Code
    4702
    Country
    CH

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Sterilizer, Steam FLE

    Proprietary Names

    Enbio S Enbio PRO

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device