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

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    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

    fPSA Rapid Test

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

    PSA Rapid Test

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

    CancerCheck® PSA

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

    CancerCheck ® fPSA

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

    Colloidal Gold Reader

    Device
    EU IVDR · Eu Ivd Class A ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·Not intended for eu market

    Atomo Diagnostics Limited

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

    fPSA Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

    PSA Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

    PSA Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

    fPSA Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

    Colloidal Gold Reader

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

    Anti-Streptolysin O (ASO) Kit(Latex Enhanced Immunoturbidimetric Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

    Anti-Streptolysin O (ASO) Kit(Latex Enhanced Immunoturbidimetric Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

    V1 061788 0008

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    No. V1 061788 0008

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    716015

    Certificate
    IVDD Annex IV Section 4·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    637070

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs