BEUDAMED
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    Hiwin Technologies Corp.

    Manufacturer
    🇹🇼 Taiwan·3 Basic UDI-DIs·3 Devices·SGS Belgium NV and SGS Belgium NV

    Kulani™ NC

    Device
    EU MDD · Eu Md Class 3 ·Meril Life Sciences Pvt. Ltd.·On the market·1 country

    Kulani™ NC - Rx PTCA Balloon Dilatation Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Meril Life Sciences Pvt. Ltd.·1 device

    Sterile Disposable Accessory for MTG-H100 with Endoscope Fastener – 4, 5, 10, 11, 12 mm

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Hiwin Technologies Corp.·1 device

    Robotic Endoscope Holder

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Hiwin Technologies Corp.·1 device

    Robotic Gait Training System

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Hiwin Technologies Corp.·1 device

    12024-2018-CE-RGC-NA-PS

    Certificate
    MDD Annex II (excluding section 4)·Hangzhou Singclean Medical Products Co., Ltd.·DNV Product Assurance AS·3 Basic UDI-DIs

    1434-MDD-257/2020, 1434-MDD-258/2020

    Certificate
    MDD Annex II Section 4·Dalim Tissen Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·12 Basic UDI-DIs

    TW19/20072

    Certificate
    MDD Annex V·Hiwin Technologies Corp.·SGS Belgium NV·1 Basic UDI-DI

    TW19/20071

    Certificate
    MDD Annex II (excluding section 4)·Hiwin Technologies Corp.·SGS Belgium NV·1 Basic UDI-DI