23 results
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27ms
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Sources: EU EUDAMED, US FDA
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Country: China
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Guangzhou AMK Medical Equipment Co.,Ltd.
Manufacturer
🇨🇳 China
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
FDA registration
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.·7 products·🇨🇳 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.
Pulse Oximeter
Device
EU MDR
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·On the market·1 country
IMDK
Device
EU MDR
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·On the market·1 country
IMDK
Device
EU MDR
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·On the market·3 countries
IMDK; imdkPortable Mesh Nebulizer;Portable Mesh Nebulizer
Device
EU MDD
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·On the market·2 countries
IMDK
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·1 device
CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Fluorescent Immunoassay Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hunan Kangxin Biotechnology Co., Ltd.·2 devices
Troponin I,CK-MB, Myoglobin Whole Blood/Serum Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.·1 device
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
Portable Mesh Nebulizer
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·1 device
Pulse Oximeter
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shenzhen IMDK Medical Technology Co.,Ltd.·2 devices
GCQ 002145 0003
Certificate
MDD Annex V·Shenzhen IMDK Medical Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI