BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    XCT 2000 X-Ray Densometer

    Reg #: 9616391 · FEI: 1000646577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRATEC MEDIZINTECHNIK GMBH
    Registration Number
    9616391
    FEI Number
    1000646577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    DURLACHER STRASSE 35
    City
    PFORZHEIM Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K983273

    Owner / Operator

    Firm Name
    STRATEC MEDIZINTECHNIK GMBH
    Operator Number
    9039947
    Address
    DURLACHER STRASSE 35, --
    City
    PFORZHEIM
    State
    DE-NOTA
    Postal Code
    75172
    Country
    DE
    Correspondent
    HARALD - SCHUBERT

    US Agent

    Business Name
    StimDesigns LLC
    Contact Name
    Marilyn Hamilton
    Address
    32683 Coast Ridge Road
    City
    Carmel
    State
    CA
    ZIP
    93923
    Country
    US
    Email
    [email protected]
    Phone
    831 2380041

    Products

    Device Name Product Code
    Densitometer, Bone KGI

    Proprietary Names

    XCT 2000 X-Ray Densometer XCT 3000 X-RAY Densiometer

    Establishment Types

    Manufacture Medical Device