BEUDAMED
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    Merlin Biomedical (Xiamen) Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

    SARS-CoV-2 Antigen Rapid Test Cassette

    Device
    EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

    SARS-CoV-2 Antigen Rapid Test Cassette

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·1 device

    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

    CeCert/037/W/E.1

    Certificate
    IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    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

    MDT Int'l SA

    Manufacturer
    🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification 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.

    Atomo Diagnostics Limited

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

    Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.

    Manufacturer
    🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    BPR Medical Limited

    Manufacturer
    44 Basic UDI-DIs·44 Devices·3 Importers·SGS Belgium NV

    Yelatma Instrument-Making Enterprise Joint-Stock Company

    Manufacturer
    🇷🇺 Russian Federation·9 Basic UDI-DIs·20 Devices·TÜV NORD CERT GmbH

    1434-IVDD-198/2022

    Certificate
    IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    V7 060578 0017

    Certificate
    IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    V7 060578 0022

    Certificate
    IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

    V7 060578 0017

    Certificate
    IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    V7 060578 0022

    Certificate
    IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    2116232DE01

    Certificate
    MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·3 Basic UDI-DIs

    2116232DE02

    Certificate
    MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·2 Basic UDI-DIs

    DGM-458

    Certificate
    IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI