14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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MAU Control
Device
EU IVDD
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Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
MAU FIA Kit
Device
EU IVDD
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Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
Microalbuminuria (MAU) Rapid Test
Device
EU IVDD
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Eu Ivd General
·Beijing Jinwofu Bioengineering Technology Co., Ltd.·On the market
MAU Rapid Quantitative Test
Device
EU IVDD
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Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Diagnostic Kit for Microalbumin (MAU) (Time-resolved Fluorescence Immunochromatographic Assay)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
MAU Control
Basic UDI-DI
EU IVDD
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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
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Eu Ivd General
·Beijing Jinwofu Bioengineering Technology Co., Ltd.·1 device
MAU Rapid Quantitative Test
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
One-Step Microalbuminuria(MAU) Test
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
Urine microalbumin (MAU) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Diagnostic Kit for Microalbumin (MAU) (Time-resolved Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
Powered wheelchair (mobility robot) (M4, M4U)
FDA 510(k)
FDA Class 2
·Physical Medicine
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