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    Filters Authorized Representative: Medunion S.L. × Notified Body: Polskie Centrum Badan I Certyfikacji S.A. × Clear all

    Jiangsu Mole Bioscience Co., LTD.

    Manufacturer
    🇨🇳 China·85 Basic UDI-DIs·316 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Assure Tech. (Hangzhou) Co., Ltd.

    Manufacturer
    🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

    SARS-CoV-2 Antigen Test Cassette

    Device
    EU IVDD · Eu Ivd Self Testing ·Jiangsu Mole Bioscience Co., LTD.·On the market

    COVID-19 Antigen Nasal Test Kit

    Device
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country

    SARS-CoV-2 Antigen Test Cassette

    Device
    EU IVDD · Eu Ivd Self Testing ·Jiangsu Mole Bioscience Co., LTD.·On the market

    SARS-CoV-2 Antigen Test Cassette

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Jiangsu Mole Bioscience Co., LTD.·1 device

    COVID-19 Antigen Nasal Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    SARS-CoV-2 Antigen Test Cassette

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Jiangsu Mole Bioscience Co., LTD.·1 device

    1434-IVDD-078/2022

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-010/2022

    Certificate
    IVDD Annex III Section 6·Jiangsu Mole Bioscience Co., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs