BEUDAMED
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    Filters Certificate Type: Ivdd Annex Iv Section 4 ×

    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.

    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.

    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

    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

    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

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

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

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

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

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

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

    Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

    Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

    HIV Rapid Test Device (Whole blood/Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    CeCert Sp. z o.o.

    Notified body
    🇵🇱 Poland·28 Manufacturers·47 Basic UDI-DIs

    General Biologicals Corporation

    Manufacturer
    🇹🇼 Taiwan·13 Basic UDI-DIs·13 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    Alba Bioscience Limited

    Manufacturer
    15 Basic UDI-DIs·15 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., 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.

    InTec PRODUCTS, INC.

    Manufacturer
    🇨🇳 China·25 Basic UDI-DIs·25 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    MP Biomedicals Asia Pacific Pte Ltd

    Manufacturer
    🇸🇬 Singapore·9 Basic UDI-DIs·9 Devices·bqs. s.r.o., bqs. s.r.o., bqs. s.r.o., and TÜV SÜD Product Service GmbH