BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating

    Reg #: 3009507273 · FEI: 3009507273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MAQUET CARDIOPULMONARY GmbH
    Registration Number
    3009507273
    FEI Number
    3009507273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kehler Strasse 31
    City
    Rastatt Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K100278

    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
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility