BEUDAMED
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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

    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.

    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

    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 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

    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

    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

    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

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

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

    No. 11 0498 CN/NB

    Certificate
    IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs

    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

    CeCert/042/W/E.1

    Certificate
    IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/044/W/E.1

    Certificate
    IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI