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    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013

    Bei Jing HeLiKang prosthetics Co.,Ltd

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device

    Xiangyang Bei Zhen Medical Equipment Co.,Ltd

    Manufacturer
    🇨🇳 China

    BEI-SURG

    Device
    EU MDD · Eu Md Class 2b ·Wuxi Beien Surgery Device Co., Ltd.·On the market·1 country

    METAL BACK AND METAGLENE GLENOID BASEPLATES [correction as of 2025-01-01]

    Device
    EU MDR · Eu Md Class 1 ·Bei Jing HeLiKang prosthetics Co.,Ltd·On the market·32 countries

    AI BEI (ZHEN JIANG) OPTICAL EYEGLASSES CO., LTD

    FDA registration
    AI BEI (ZHEN JIANG) OPTICAL EYEGLASSES CO., LTD·5 products·🇨🇳 China

    HONG BO (HU BEI) MEDICAL PRODUCTS CO., LTD

    FDA registration
    HONG BO (HU BEI) MEDICAL PRODUCTS CO., LTD·2 products·🇨🇳 China

    GRI Medical & Electronic Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·115 Basic UDI-DIs·2024 Devices·2 Importers·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    GE Healthcare Tianjin Company Limited

    Manufacturer
    🇨🇳 China·13 Basic UDI-DIs·17 Devices

    GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Manufacturer
    🇨🇳 China·TÜV Rheinland LGA Products GmbH

    GE Healthcare Tianjin Company Limited

    Manufacturer
    🇨🇳 China·TÜV Rheinland LGA Products GmbH

    GE Medical Systems CO. Ltd

    Manufacturer
    🇨🇳 China·17 Basic UDI-DIs·35 Devices

    GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Manufacturer
    🇨🇳 China·9 Basic UDI-DIs·15 Devices

    GE HUALUN MEDICAL SYSTEMS CO. Ltd

    Manufacturer
    🇨🇳 China·TÜV Rheinland LGA Products GmbH

    GE HUALUN MEDICAL SYSTEMS CO. Ltd

    Manufacturer
    🇨🇳 China·7 Basic UDI-DIs·7 Devices·GMED SAS

    Vital Comfort Handgelenkbandage bei Arthrose und Karpaltunnel rechts, 1 Stück

    Device
    EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·On the market

    Vital Comfort Handgelenkbandage bei Arthrose und Karpaltunnel links, 1 Stück

    Device
    EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·On the market

    Lower Limb/Upper Limb Prosthetics Parts

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Bei Jing HeLiKang prosthetics Co.,Ltd·1 device

    Vital Comfort Handgelenkbandage bei Arthrose und Karpaltunnel rechts, 1 Stück

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·1 device

    Vital Comfort Handgelenkbandage bei Arthrose und Karpaltunnel links, 1 Stück

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·1 device