BEUDAMED
    155 results · 9ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Authorized Representative: Medunion S.L. ×

    SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）

    Device
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·On the market

    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

    Hangzhou Realy Tech Co.,Ltd.

    Manufacturer
    🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

    Manufacturer
    🇨🇳 China·29 Basic UDI-DIs·29 Devices·4 Importers·Sertio Oy, TÜV SÜD Product Service GmbH, 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.

    Hangzhou Laihe Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

    Shanghai BioGerm Medical Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·9 Basic UDI-DIs·9 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Jiangsu Mole Bioscience Co., LTD.

    Manufacturer
    🇨🇳 China·85 Basic UDI-DIs·316 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    W.H.P.M. Bioresearch & Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·27 Basic UDI-DIs·27 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

    CeCert/068/W/E.2

    Certificate
    IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/077/W/E.1

    Certificate
    IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    2020-IVD/DE-006/A

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

    1434-IVDD-076/2022

    Certificate
    IVDD Annex III Section 6·Shanghai BioGerm Medical Technology Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

    No. 1434-IVDD-055/2022

    Certificate
    IVDD Annex III Section 6·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    CeCert/100/W/E.1

    Certificate
    IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/025/W/E.1

    Certificate
    IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/081/W/E.4

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    1434-IVDD-078/2022

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    244409553-200

    Certificate
    IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    1434-IVDD-010/2022

    Certificate
    IVDD Annex III Section 6·Jiangsu Mole Bioscience Co., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    CeCert/036/W/E.1

    Certificate
    IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI