6 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: China
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CRP/MxA Combo Rapid Test
Device
EU IVDD
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Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·On the market
CRP/MxA Combo Rapid Test
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
BLOOM MAX LIMITED
FDA registration
BLOOM MAX LIMITED·3 products·🇨🇳 China
Jiaxing Max Hosiery Co.,Ltd.
FDA registration
Jiaxing Max Hosiery Co.,Ltd.·8 products·🇨🇳 China
JINHUA QUAL-MAX TRADING CO., LTD
FDA registration
JINHUA QUAL-MAX TRADING CO., LTD·3 products·🇨🇳 China
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021