BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Bite Away

    Reg #: 3015733772 · FEI: 3015733772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIBETEC GMBH
    Registration Number
    3015733772
    FEI Number
    3015733772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Munchener Strasse 15
    City
    Sandersdorf-Brehna Saxony-Anhalt
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K160943

    Owner / Operator

    Firm Name
    MibeTec GmbH
    Operator Number
    10060938
    Address
    Munchener Strasse 15
    City
    Sandersdorf-Brehna
    State
    Saxony-Anhalt
    Postal Code
    06796
    Country
    DE
    Correspondent
    Kenneth K Kleinhenz

    US Agent

    Business Name
    QSR Consulting
    Contact Name
    Kenneth Kleinhenz
    Address
    4141 Elm Rd.
    City
    Hudson
    State
    MI
    ZIP
    49247
    Country
    US
    Email
    [email protected]
    Phone
    619 2449573

    Products

    Device Name Product Code
    Pad, Heating, Powered IRT

    Proprietary Names

    Bite Away

    Establishment Types

    Manufacture Medical Device