BEUDAMED
    124 results · 17ms · Sources: EU EUDAMED, US FDA

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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.

    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

    Atomo Diagnostics Limited

    Manufacturer
    🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Sanway Gene Tech. Inc.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    bioLytical Laboratories Inc.

    Manufacturer
    🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

    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

    HIV MULTIPLE ANTIBODY

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

    HCV ANTIBODY (TOTAL)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

    HCV ANTIBODY (TOTAL)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

    HCV ANTIBODY (TOTAL)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

    HIV MULTIPLE ANTIBODY

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

    HIV MULTIPLE ANTIBODY

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

    HIV MULTIPLE ANTIBODY

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

    HCV ANTIBODY (TOTAL)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    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