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    RHEUMATOID FACTORS

    Device
    EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

    1434-IVDD-174/2022

    Certificate
    IVDD Annex III Section 6·Maccura Biotechnology Co., Ltd. ·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·28 Basic UDI-DIs

    No. V1 059892 0009

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Maccura Biotechnology Co., Ltd. ·TÜV SÜD Product Service GmbH·110 Basic UDI-DIs

    No.V1 0598920009

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Maccura Biotechnology Co., Ltd. ·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    HZ 2010527-1

    Certificate
    MDR QMS·WUHAN HUAWEI TECHNOLOGY CO.,LTD·TÜV Rheinland LGA Products GmbH