BEUDAMED
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    HAS-BLED Score

    Device
    EU MDR · Eu Md Class 2a ·Evidencio·On the market·2 countries

    HAS-BLED Score for Major Bleeding Risk Calculator

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Evidencio·1 device

    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

    FDA Enforcement
    Class III ·Terminated·ELITech Group B.V.·October 9, 2019

    SUNGO Europe B.V.

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