BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Custodiol

    Reg #: 9615922 · FEI: 3001640191 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DR. FRANZ KOHLER CHEMIE GMBH
    Registration Number
    9615922
    FEI Number
    3001640191
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WERNER-VON-SIEMENS-STR. 14-28
    City
    BENSHEIM Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K043461

    Owner / Operator

    Firm Name
    DR. FRANZ KOHLER CHEMIE GMBH
    Operator Number
    9034968
    Address
    Werner-von-Siemens-Strasse 14-28, --
    City
    Bensheim
    State
    Hesse
    Postal Code
    D-64625
    Country
    DE
    Correspondent
    Clifton W Czarnojon

    US Agent

    Business Name
    SpectraMedEx, LLC
    Contact Name
    John Ziobro
    Address
    S6W31134 Hidden Hollow
    City
    Delafield
    State
    WI
    ZIP
    53018
    Country
    US
    Email
    [email protected]
    Phone
    262 7198922

    Products

    Device Name Product Code
    Set, Perfusion, Kidney, Disposable KDL
    System And Accessories, Isolated Heart, Transport And Preservation MSB

    Proprietary Names

    Custodiol

    Establishment Types

    Manufacture Medical Device