BEUDAMED
    1,155 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. ×

    III Type Procollagen Kit (CLIA)

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

    Calcium Kit (Arsenazo III Method)

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

    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.

    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.

    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

    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

    Lysing Solution

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Shenzhen Hailife Biotechnology Co., Ltd.·2 devices

    25-OH Vitamin D Chemiluminescence Immunoassay Test Kit

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

    H. pylori Antibody FIA

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

    Concentrated Wash Solution

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·MedicalSystem Biotechnology Co., Ltd.·1 device

    Transferrin Rapid Quantitative Test(Chemiluminescence Immunoassay)

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

    Novel Coronavirus (SARSCoV-2) Real Time Multiplex RT-PCR Kit

    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

    Virus RNA Collection Kit

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

    Meperidine Rapid Test

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

    Faecal Occult Blood Fecal Test Kit

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

    Alanine Aminotransferase Kit (Kinetic Method)

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

    Urine Formed Element Kit

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

    COVID-19 & Influenza Antigen Rapid Test Cassette

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