BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EKF DIAGNOSTIC GMBH

    Reg #: 3004838836 · FEI: 3004838836 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EKF DIAGNOSTIC GMBH
    Registration Number
    3004838836
    FEI Number
    3004838836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EBENDORFER CHAUSEE 3
    City
    BARLEBEN/MADGEBURG Saxony-Anhalt
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK110036

    Owner / Operator

    Firm Name
    EKF DIAGNOSTIC GMBH
    Operator Number
    9057009
    Address
    EBENDORFER CHAUSEE 3, BARLEBEN/MADGEBURG
    City
    SAXONY-ANHALT
    State
    DE-NOTA
    Postal Code
    D-39179
    Country
    DE

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    System, Hemoglobin, Automated GKR

    Establishment Types

    Manufacture Medical Device