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    SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

    Device
    EU IVDR · Eu Ivd Class C ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market·11 countries

    Apolipoprotein A-I Kit (Immunoturbidimetric Method)

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

    ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

    Manufacturer
    🇨🇳 China·29 Basic UDI-DIs·29 Devices·4 Importers·Sertio Oy, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., 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 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·1 device

    MedicalSystem Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·276 Basic UDI-DIs·279 Devices

    BioTeke Corporation（Wuxi）Co., Ltd

    Manufacturer
    🇨🇳 China·4 Basic UDI-DIs·10 Devices

    W.H.P.M. Bioresearch & Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·27 Basic UDI-DIs·27 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

    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

    Xiamen Biotime Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·399 Basic UDI-DIs·401 Devices

    Hangzhou Laihe Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

    EU-TDA-FI-20642-800030-2025-1

    Certificate
    IVDR Technical Documentation·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·Sertio Oy·1 Basic UDI-DI

    BIOTIME

    Device
    EU IVDR · Eu Ivd Class A ·Xiamen Biotime Biotechnology Co., Ltd.·On the market

    Hitergent

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries

    ISE Diluent

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries

    ISE Detergent

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries

    Alkali Detergent

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries

    Acid Detergent

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries

    Automated Hematology Analyzer Diluent

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries

    Automated Hematology Analyzer Lyse

    Device
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·On the market·4 countries