BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET

    Reg #: 3005792925 · FEI: 3005792925 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TEM Innovations GmbH
    Registration Number
    3005792925
    FEI Number
    3005792925
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Martin-Kollar Strasse, 15
    City
    Munich Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K101533

    Owner / Operator

    Firm Name
    TEM Innovations GmbH
    Operator Number
    10031957
    Address
    Martin-Kollar-Strasse 15
    City
    Munich
    State
    Bavaria
    Postal Code
    81829
    Country
    DE
    Correspondent
    David Jacob

    Products

    Device Name Product Code
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device