8 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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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
β-CTX CLIA Microparticles
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·2 devices
CTX-M β-lactamases Rapid Test
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
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
Vibrio Cholera （Gene CTX）Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·1 device
Vibrio Cholera CTX Gene/O1/O139 Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·1 device