BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HIT-Set Advanced 7 and 5 (SOFTLINE Coating)

    Reg #: 8010762 · FEI: 3009649876 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    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
    K112360

    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
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    HIT-Set Advanced 7 and 5 (SOFTLINE Coating) HLS-Set Advanced 7 and 5 (with BIOLINE Coating)

    Establishment Types

    Manufacture Medical Device