BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CARDIOHELP-I, CARDIOHELP Emergency Drive, Accessories

    Reg #: 3007427881 · FEI: 3007427881 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIKOMP GMBH
    Registration Number
    3007427881
    FEI Number
    3007427881
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kehler Strasse 31
    City
    Rastatt Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K133598

    Owner / Operator

    Firm Name
    MediKomp GmbH
    Operator Number
    10031001
    Address
    KEHLER STRASSE 31
    City
    Rastatt
    State
    Baden-Wurttemberg
    Postal Code
    76437
    Country
    DE
    Correspondent
    Tom Peters

    Products

    Device Name Product Code
    Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ

    Proprietary Names

    CARDIOHELP-I, CARDIOHELP Emergency Drive, Accessories

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)