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    IMD CHINA CO.,LTD.

    Manufacturer
    🇨🇳 China

    IM2 Ultrasonic Scaler Tips

    Device
    EU MDR · Eu Md Class 2a ·URIT Medical Electronic Co.,Ltd.·On the market·1 country

    IM1 Ultrasonic Scaler Tips

    Device
    EU MDR · Eu Md Class 2a ·URIT Medical Electronic Co.,Ltd.·On the market·1 country

    ZD Medical Inc.

    Manufacturer
    🇨🇳 China·2 Basic UDI-DIs·2 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Fluorescent Immunoassay Analyzer

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Hunan Kangxin Biotechnology Co., Ltd.·2 devices

    Ischemia Modified Albumin （IMA）Assay Kit （Albumin Cobalt Binding Method）

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

    VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

    Device
    EU MDD · Eu Md Class 2a ·ZD Medical Inc.·On the market·2 countries

    VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

    Device
    EU MDD · Eu Md Class 2a ·ZD Medical Inc.·On the market·2 countries

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019

    Immunoassay Multi Control

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    Vein Finder System

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·ZD Medical Inc.·1 device

    Vein Finder System

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·ZD Medical Inc.·1 device

    2034/MDD

    Certificate
    MDD Annex II (excluding section 4)·ZD Medical Inc.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·2 Basic UDI-DIs