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    EKF-diagnostic GmbH

    Manufacturer
    🇩🇪 Germany

    EKF DIAGNOSTIC GMBH

    FDA registration
    EKF DIAGNOSTIC GMBH·4 products·🇩🇪 Germany

    Add Pack Hemo Control DM

    FDA UDI
    EKF-diagnostic GmbH·04048534002189·For the quantitative determination of hemoglobi...

    DiaSpect Tm

    FDA UDI
    EKF-diagnostic GmbH·04048534001946·For the quantitative determination of hemoglobi...

    DiaSpect Tm

    FDA UDI
    EKF-diagnostic GmbH·04048534002165·For the quantitative determination of hemoglobi...

    Hemo Control

    FDA UDI
    EKF-diagnostic GmbH·04048534002028·For the quantitative determination of hemoglobi...

    Hemo Control Hemoglobin Microcuvette

    FDA UDI
    EKF-diagnostic GmbH·04048534000031·For the quantitative determination of hemoglobi...

    DiaSpect Control HBT1

    FDA UDI
    EKF-diagnostic GmbH·14048534001974·For the verification of the precision and accur...

    DiaSpect Tm Cuvettes

    FDA UDI
    EKF-diagnostic GmbH·14048534001967·For the quantitative determination of hemoglobi...

    DiaSpect Control HBT4

    FDA UDI
    EKF-diagnostic GmbH·04048534002004·For the verification of the precision and accur...

    Cleaner

    FDA UDI
    EKF-diagnostic GmbH·04048534000840·For Cleaning the optical unit of Hemo Control A...

    DiaSpect Control HBT2

    FDA UDI
    EKF-diagnostic GmbH·14048534001981·For the verification of the precision and accur...

    DiaSpect Control HBT3

    FDA UDI
    EKF-diagnostic GmbH·14048534001998·For the verification of the precision and accur...

    EKF Link

    FDA UDI
    EKF-diagnostic GmbH·04048534002011·EKF Link is a data and device management system...

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·September 5, 2018

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Recall
    Terminated ·Product code GKR·February 8, 2018

    EKF-diagnostic GmbH

    Authorized representative
    🇩🇪 Germany

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices