5 results
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29ms
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Sources: EU EUDAMED, US FDA
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Country: China
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BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026
LIA-ANA-Profile
Basic UDI-DI
EU IVDD
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Eu Ivd General
·SHENZHEN YHLO BIOTECH 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