BEUDAMED
    64 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Certificate Type: Ivdd Annex Iv Section 4 ×

    Abon Biopharm(Hangzhou) Co., Ltd

    Manufacturer
    🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

    HCV ANTIBODY -RT & POC

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

    HBSAG - RT & POC

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

    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

    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.

    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.

    Atomo Diagnostics Limited

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

    Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

    Manufacturer
    🇵🇱 Poland·30 Basic UDI-DIs·32 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

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

    HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

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

    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

    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