BEUDAMED
    68 results · 7ms · 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.

    Vela Operations Singapore Pte. Ltd.

    Manufacturer
    🇸🇬 Singapore·75 Basic UDI-DIs·82 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Abbott Diagnostics Medical Co., Ltd.

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    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

    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

    Jiangxi Aicare Medical Technology Co.,Ltd

    Manufacturer
    🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    Tianjin HUAC Healthcare Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products 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

    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

    HIV 1 / 2 - RT & POC

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

    HCV ANTIBODY -RT & POC

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

    Sentosa SQ HIV Genotyping Assay (4x16)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Vela Operations Singapore Pte. Ltd.·On the market

    Sentosa SQ HCV Genotyping Assay Bundle (4x16)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Vela Operations Singapore Pte. Ltd.·On the market

    HBSAG - RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) 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

    Determine

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market

    HIV AG/AB COMBI - RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries

    SARS-CoV-2 Antigen Rapid Tests for Self-Testing

    Device
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

    HUAC

    Device
    EU IVDD · Eu Ivd Self Testing ·Tianjin HUAC Healthcare Technology Co., Ltd.·On the market·3 countries