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

    QUIK-CHECK 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-C111-2017R6
    Basic UDI-DI Code
    B-C111-2017R6
    Reference
    C111-2017
    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 QUIK-CHECK 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 QUIK-CHECK Cholesterol Meter. The QUIK-CHECK Cholesterol Monitoring System consists of QUIK-CHECK Cholesterol Meter, QUIK-CHECK Cholesterol Test Devices and QUIK-CHECK 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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