BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Stoeckert Heater-Cooler System 3T

    Reg #: 3001588119 · FEI: 3001588119 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LAUDA DR. R. WOBSER GMBH & CO. KG
    Registration Number
    3001588119
    FEI Number
    3001588119
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lauda-Koeningshofen
    City
    Laudaplatz 1 Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191402

    Owner / Operator

    Firm Name
    LAUDA DR. R. WOBSER GMBH & CO. KG
    Operator Number
    10049791
    Address
    97912 Lauda-Koeningshofen, Laudaplatz 1
    City
    Lauda-Koenigshofen
    State
    Baden-Wurttemberg
    Postal Code
    97922
    Country
    DE
    Correspondent
    Juergen Kraus

    US Agent

    Business Name
    LAUDA-Brinkmann, LP
    Contact Name
    Michael Faulkner
    Address
    1819 Underwood Blvd
    City
    Delran
    State
    NJ
    ZIP
    08075
    Country
    US
    Email
    [email protected]
    Phone
    631 8737998

    Products

    Device Name Product Code
    Controller, Temperature, Cardiopulmonary Bypass DWC

    Proprietary Names

    Stoeckert Heater-Cooler System 3T

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)