6 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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OUR UNITED CORPORATION
FDA registration
OUR UNITED CORPORATION·2 products·🇨🇳 China
EXR 120
Device
EU IVDR
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Eu Ivd Class A
·Zybio Inc.·On the market
OUR SMD MEDICAL (WUHAN) CO., LTD.
FDA registration
OUR SMD MEDICAL (WUHAN) CO., LTD.·1 product·🇨🇳 China
DXR Mechanical Accessories
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Philips Healthcare (Suzhou) Co., Ltd.·10 devices
GE Proteus XR/A radiographic system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 4, 2024
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·September 4, 2024