BEUDAMED
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    VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

    Device
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

    VIROLOGY - NA REAGENTS - OTHER

    Device
    EU IVDD · Eu Ivd General ·Daan Gene Co., Ltd.·On the market

    Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

    Device
    EU IVDD · Eu Ivd General ·BioDetect（Xiamen）Biotechnology Co., Ltd.·On the market

    DP360 Slide Stainer

    Device
    EU IVDR · Eu Ivd Class A ·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries

    Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

    Manufacturer
    🇨🇳 China·91 Basic UDI-DIs·115 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    JOYSBIO(Tianjin) Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·5 Basic UDI-DIs·5 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Jiangsu Mole Bioscience Co., LTD.

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

    BioDetect（Xiamen）Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·20 Basic UDI-DIs·20 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Nanjing Synthgene Medical Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·83 Basic UDI-DIs·83 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Beijing North Institute of Biotechnology Co.,Ltd.

    Manufacturer
    🇨🇳 China·13 Basic UDI-DIs·13 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

    Manufacturer
    🇨🇳 China·43 Basic UDI-DIs·43 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Anbio (Xiamen) Biotechnology Co.,Ltd.

    Manufacturer
    🇨🇳 China·32 Basic UDI-DIs·35 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Nanjing Genscript Diagnostics Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·2 Basic UDI-DIs·2 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    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.

    SHANGHAI ZJ BIO-TECH CO., LTD

    Manufacturer
    🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH

    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.

    Analysis Software for PCR-Fluorescence Detection Data

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Detection Kit for 2019-nCoV (PCR-Fluorescence)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Daan Gene Co., Ltd.·1 device