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

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    Human Xtensions Ltd.

    Manufacturer
    🇮🇱 Israel·2 Basic UDI-DIs·3 Devices·1 Importer

    Gmate® Blood Glucose Test Strips

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·GB Lifecare Co., Ltd.·On the market·4 countries

    Gmate® Origin

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·GB Lifecare Co., Ltd.·On the market·4 countries

    HandX Needle Holder

    Device
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·On the market·5 countries

    HandX Handpiece

    Device
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·On the market·5 countries

    HandX Self- righting Needle Holder

    Device
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·On the market·5 countries

    Gmate® Blood Glucose Test Strip

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·GB Lifecare Co., Ltd.·1 device

    Gmate® Origin

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·GB Lifecare Co., Ltd.·1 device

    HL60145538

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·GB Lifecare Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

    HandX Needle Holder

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·2 devices

    HandX Handpiece

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·1 device