BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    TEM Innovations GmbH

    Reg #: 3005792925 · FEI: 3005792925 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    TEM Innovations GmbH
    Registration Number
    3005792925
    FEI Number
    3005792925
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Martin-Kollar Strasse, 15
    City
    Munich Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K083842

    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
    Plasma, Coagulation Control GGN
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    ROTROL P ROTROL N NATEM Assay in-TEM Assay hep-TEM Assay ROTEM Delta Instrument star-TEM EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET ROTEM sigma Thromboelastometry System ROTEM sigma ROTROL P ROTEM sigma complete + hep ROTEM sigma ROTROL N

    Establishment Types

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