BEUDAMED
    Eu Ivdd Eu Ivd Self Testing On The Market 🇨🇳 China

    Mission Cholesterol Monitoring System

    Acon Biotech (Hangzhou) Co., Ltd. · 🇨🇳 China
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    0
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-C111-2011QS
    Basic UDI-DI Code
    B-C111-2011QS
    Reference
    C111-2011
    Device Types
    None provided
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd Self Testing
    Status
    On The Market
    Manufacturer
    Acon Biotech (Hangzhou) Co., Ltd.

    Additional Description

    The Mission Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol (CHOL), High-Density Lipoprotein (HDL), and Triglycerides (TRIG) in capillary and venous whole blood, serum and plasma. The value of Low-Density Lipoprotein (LDL) and the ratio of CHOL/HDL are calculated by the Mission Cholesterol Meter. The Mission Cholesterol Monitoring System consists of Mission Cholesterol Meter, Mission Cholesterol Test Devices and Mission Cholesterol Control Solution, and it is for self-testing and professional use.

    CND Nomenclature Codes

    Code Description
    W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
    W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
    W010106010801 BLOOD TEST STRIPS CONTROLS

    Certificates

    Type Number
    IVDD Annex IV (excluding sections 4, 6) V1 042074 0026

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