BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Dimension CA Flex

    Reg #: 9610806 · FEI: 3001644026 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    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
    K860021

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Dimension CA Flex Dimension CHEM I Cal Dimension Cuvette Cartridge Purified Water Diluent QuikLyte IMT Std B Dimension Enzyme Verifier Dimension BUN Flex Dimension Sample Cups with Lids Dimension Salt Bridge Solution QuikLYTE IMT Std A

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)