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    REMEDI Inc.

    Manufacturer
    🇰🇷 South Korea·5 Basic UDI-DIs·5 Devices·MTIC InterCert S.r.l.

    REMEDI INC.

    FDA registration
    REMEDI INC.·3 products·🇰🇷 South Korea

    MOBILE RADIOGRAPHIC UNITS

    Device
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·On the market·15 countries

    X-RAY TUBE ASSEMBLY

    Device
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·On the market·1 country

    X-RAY TUBE ASSEMBLY

    Device
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·On the market·1 country

    REMEX-K100

    Device
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·On the market·14 countries

    MOBILE RADIOGRAPHIC UNITS

    Device
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·On the market·14 countries

    Stationary Anode X-ray tube

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·1 device

    Stationary Anode X-ray tube

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·1 device

    Portable X-ray equipment

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·1 device

    Portable X-ray equipment

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·1 device

    Portable X-ray equipment

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·REMEDI Inc.·1 device

    0068/QCO-DM/072-2017

    Certificate
    MDD Annex II (excluding section 4)·REMEDI Inc.·MTIC InterCert S.r.l.·5 Basic UDI-DIs

    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code OWB·February 23, 2017

    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code OWB·April 15, 2016

    Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code OWB·April 15, 2016

    Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code JAA·April 15, 2016

    Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code OWB·April 15, 2016

    Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code OWB·April 15, 2016

    Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code JAA·April 15, 2016