BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    INNOVANCE Heparin

    Reg #: 9610806 · FEI: 3001644026 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Products GmbH
    Registration Number
    9610806
    FEI Number
    3001644026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    76 EMIL-VON-BEHRING STRASSE
    City
    MARBURG Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K162540

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Plasma, Coagulation Control GGN
    Assay, Heparin KFF
    Calibrator, Primary JIS

    Proprietary Names

    INNOVANCE Heparin INNOVANCE Heparin LMW Control 1 INNOVANCE Heparin UF Control 1 INNOVANCE Heparin UF Control 2 INNOVANCE Heparin Calibrator INNOVANCE Heparin LMW Control 2

    Establishment Types

    Manufacture Medical Device