25 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Powered wheelchair (mobility robot) (M4, M4U)
FDA 510(k)
FDA Class 2
·Physical Medicine
MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd
FDA registration
MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd·1 product·🇨🇳 China
WASHING, BATHING AND SHOWERING DEVICES - OTHER
Device
EU MDR
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Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·On the market
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·On the market
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·On the market
PERSONAL MOBILITY DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·On the market
PERSONAL MOBILITY DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·On the market
MAU Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
MAU FIA Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
Microalbuminuria (MAU) Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beijing Jinwofu Bioengineering Technology Co., Ltd.·1 device
MAU Rapid Quantitative Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025
One-Step Microalbuminuria(MAU) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
Urine microalbumin (MAU) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Aluminum ladder
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·1 device
Grab bar
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·1 device
Shower chair
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·1 device
Medical waste truck
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Taizhou Uru Medical Equipment Co., Ltd·1 device