BEUDAMED
    76 results · 8ms · 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. ×

    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

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

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

    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

    Dengue IgG/IgM Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

    Mycoplasmal Pneumonia IgM Rapid Qualitative Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

    SARS-CoV-2 IgG/IgM Control Set

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

    Hepatitis A Virus IgG/IgM Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    Dengue IgG/IgM and NS1 Rapid Test Device

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

    Dengue IgG/IgM and NS1 Rapid Test Device

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

    SARS-CoV-2 IgG/IgM Rapid Qualitative Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

    Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·1 device

    COVID-19 Ag and IgG/IgM Ab Combo Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

    Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

    SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

    COVID-19 Ag and IgG/IgM Ab(High Sensitivity) Combo Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

    CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·On the market

    One-Step Drug of Abuse Test Tricyclic Antidepressants (TCA)

    Device
    EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

    One-Step Drug of Abuse Test -Methylenedioxymethamphetamine (MDMA)

    Device
    EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

    One-Step Drug Of Abuse Test 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP)

    Device
    EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

    One-Step Drug Of Abuse Test -Morphine (MOR)

    Device
    EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market