BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    RotaFlow Centrifugal Pump with BIOLINE Coating

    Reg #: 8010762 · FEI: 3009649876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MAQUET CARDIOPULMONARY GmbH
    Registration Number
    8010762
    FEI Number
    3009649876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Neue Rottenburger Strasse 37
    City
    Hechingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K080470

    Owner / Operator

    Firm Name
    Maquet Cardiopulmonary GmbH
    Operator Number
    8010762
    Address
    Kehler Strasse 31
    City
    Rastatt
    State
    Baden-Wurttemberg
    Postal Code
    76437
    Country
    DE
    Correspondent
    Tom Peters

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM

    Proprietary Names

    RotaFlow Centrifugal Pump with BIOLINE Coating

    Establishment Types

    Manufacture Medical Device