BEUDAMED
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    Daan Gene Co., Ltd.

    Manufacturer
    🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    Hangzhou Realy Tech Co.,Ltd.

    Manufacturer
    🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    Sansure Biotech Inc.

    Manufacturer
    🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Dynamiker Biotechnology (Tianjin) Co., Ltd.

    Manufacturer
    🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.

    Suny (Xiamen) Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·CeCert Sp. z o.o.

    Shenzhen Zijian Biotechnology Co., Ltd

    Manufacturer
    🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

    Zhongshan Bio-Tech Co., Ltd.

    Manufacturer
    🇨🇳 China·24 Basic UDI-DIs·24 Devices·CeCert Sp. z o.o. and 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

    Hangzhou Alltest Biotech.Co.,Ltd.

    Manufacturer
    🇨🇳 China·119 Basic UDI-DIs·171 Devices·32 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

    Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market·3 countries

    Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

    HEPATITIS C VIRUS - NA REAGENTS

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·On the market

    HEPATITIS B VIRUS - NA REAGENTS

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·On the market

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

    BOIRON TEST & CARE

    Device
    EU IVDD · Eu Ivd Self Testing ·Suny (Xiamen) Biotechnology Co., Ltd.·On the market·31 countries

    HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

    HBsAg Rapid Test Cassette

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

    HBsAg Rapid Test Cassette

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market