BEUDAMED
    44 results · 17ms · 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 Certificate Type: Ivdd Annex Iii Section 6 ×

    Labsystems Diagnostics Oy

    Manufacturer
    🇫🇮 Finland·74 Basic UDI-DIs·75 Devices·Eurofins Electric & Electronics Finland Oy, Eurofins Electric & Electronics Finland Oy, and Eurofins Electric & Electronics Finland Oy

    Shenzhen Zijian Biotechnology Co., Ltd

    Manufacturer
    🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

    Calpro AS

    Manufacturer
    🇳🇴 Norway·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy

    Biocard™ Celiac Home

    Device
    EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·On the market

    CalproSmart Self-Test

    Device
    EU IVDD · Eu Ivd Self Testing ·Calpro AS·On the market·15 countries

    Biocard™ H pylori IgG Home

    Device
    EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·On the market

    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.

    Calprosmart Self-Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Calpro AS·1 device

    3-018-200

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·1 device

    Biocard™ Celiac Home

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·1 device

    C-02-1206-801-22

    Certificate
    IVDD Annex III Section 6·Calpro AS·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

    C-02-1172-802-22

    Certificate
    IVDD Annex III Section 6·Labsystems Diagnostics Oy·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

    C-02-1172-804-22

    Certificate
    IVDD Annex III Section 6·Labsystems Diagnostics Oy·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

    TÜV Rheinland LGA Products GmbH

    Notified body
    🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs

    Eurofins Electric & Electronics Finland Oy

    Notified body
    🇫🇮 Finland·78 Manufacturers·851 Basic UDI-DIs

    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

    1434-IVDD-068/2022

    Certificate
    IVDD Annex III Section 6·Anbio (Xiamen) Biotechnology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·5 Basic UDI-DIs

    CECERT/073/W/E.2

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

    No. 1434-IVDD-228/2022

    Certificate
    IVDD Annex III Section 6·Nantong EgensBiotechnology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·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