BEUDAMED
    26 results · 9ms · 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: Cmc Medical Devices & Drugs Sl × Competent Authority: Ministry Of Health, Welfare And Sports × Clear all

    Maramco for international trade

    Manufacturer
    🇪🇬 Egypt·8 Basic UDI-DIs·8 Devices·TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and SGS Belgium NV

    Shenzhen Zijian Biotechnology Co., Ltd

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

    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

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

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

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

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

    HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

    COVID-19 & Influenza A/B Antigen Nasal Test Kit

    Device
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country

    DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

    Device
    EU MDD · Eu Md Class 2a ·Maramco for international trade·On the market·2 countries

    DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

    Device
    EU MDD · Eu Md Class 2a ·Maramco for international trade·On the market·2 countries

    DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

    Device
    EU MDD · Eu Md Class 2a ·Maramco for international trade·On the market·2 countries

    DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

    Device
    EU MDD · Eu Md Class 2a ·Maramco for international trade·On the market·2 countries

    SOLUTIONS FOR ADHESIVE TAPE REMOVAL

    Device
    EU MDD · Eu Md Class 1 ·Maramco for international trade·On the market

    HIV Rapid Test Device (Whole blood/Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

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

    SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

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

    COVID-19 & Influenza A/B Antigen Nasal Test Kit

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

    CeCert/077/W/E.1

    Certificate
    IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/081/W/E.4

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/086/W/E.1

    Certificate
    IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs

    Nelaton Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Maramco for international trade·1 device