BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MIBETEC U.S.

    Reg #: 3015633277 · FEI: 3015633277 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    MIBETEC U.S.
    Registration Number
    3015633277
    FEI Number
    3015633277
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5826 New Territory Boulevard, Suite #1039
    City
    Sugar Land
    State
    TX
    ZIP
    77479
    Country
    US

    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

    Products

    Device Name Product Code
    Pad, Heating, Powered IRT

    Proprietary Names

    Bite Away

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198