BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Novalung

    Reg #: 3016096143 · FEI: 3016096143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TST GmbH
    Registration Number
    3016096143
    FEI Number
    3016096143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Marie-Curie-Str. 1a
    City
    Gernsheim Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191407

    Owner / Operator

    Firm Name
    FRESENIUS MEDICAL CARE
    Operator Number
    8010838
    Address
    ELSE KROENER-STRASSE 1, --
    City
    BAD HOMBURG
    State
    Hesse
    Postal Code
    D-61352
    Country
    DE

    US Agent

    Business Name
    VP Regulatory Affairs
    Contact Name
    Denise Oppermann
    Address
    920 Winter St
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479 ext. 0

    Products

    Device Name Product Code
    Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ

    Proprietary Names

    Novalung

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device