18 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: China
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ZD Medical Inc.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Fluorescent Immunoassay Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hunan Kangxin Biotechnology Co., Ltd.·2 devices
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
HAV IgM Rapid Test Cassette (Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Orient Gene Biotech Co., Ltd·1 device
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
Spacer Block (1mm)
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
2. 1mm Emergency Screw(Self-tapping)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device
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