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    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·August 5, 2020

    Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·August 5, 2020

    Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·August 5, 2020

    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·May 1, 2013

    Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·July 29, 2020

    FOX OPTICS INC.

    FDA registration
    FOX OPTICS INC.·5 products·🇨🇳 China

    Shenzhen Fox Hunting E-commerce Co., Ltd

    FDA registration
    Shenzhen Fox Hunting E-commerce Co., Ltd·7 products·🇨🇳 China

    Multigate Co., Ltd

    Manufacturer
    🇨🇳 China·48 Basic UDI-DIs·331 Devices

    RFX+CARE Manufacturing Co., Ltd.

    Manufacturer
    🇨🇳 China·104 Basic UDI-DIs·315 Devices·5 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Ice Bag L

    Device
    EU MDR · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·On the market·2 countries

    Cleansing Wipe

    Device
    EU MDR · Eu Md Class 2a ·RFX+CARE Manufacturing Co., Ltd.·On the market·2 countries

    Cleansing Wipe

    Device
    EU MDR · Eu Md Class 2a ·RFX+CARE Manufacturing Co., Ltd.·On the market·2 countries

    Cleansing Wipe

    Device
    EU MDR · Eu Md Class 2a ·RFX+CARE Manufacturing Co., Ltd.·On the market·2 countries

    Glitter plaster 24p

    Device
    EU MDR · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·Not intended for eu market

    Neon plaster 24p

    Device
    EU MDR · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·Not intended for eu market

    Sterile Hydrocolloid dressing

    Device
    EU MDR · Eu Md Class 2a ·RFX+CARE Manufacturing Co., Ltd.·On the market·2 countries

    Cleansing Wipe

    Device
    EU MDR · Eu Md Class 2a ·RFX+CARE Manufacturing Co., Ltd.·On the market·2 countries