Mindray Bio-Medical Electronics Co., Ltd. is one of 1971 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Mindray Bio-Medical Electronics Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: BC-5390 Auto Hematology Analyzer, BC-3600 Auto Hematology Analyzer
2
Total
2
Cleared
0
Denied
Mindray Bio-Medical Electronics Co., Ltd. is a medical technology and solutions supplier with a manufacturing facility in Shenzhen, China. The company specializes in diagnostic and clinical care devices across multiple healthcare settings.
Mindray has received 2 FDA 510(k) clearances from 2 total submissions. The company's regulatory focus centers on Hematology devices, which represent 100% of its FDA submissions. Clearances were granted between 2015 and 2016. The company has not submitted new 510(k) applications in more than five years and should be treated as a historical regulatory record.
Historical cleared devices include auto hematology analyzers designed for laboratory and clinical diagnostics. These instruments reflect the company's core expertise in blood analysis and automated laboratory testing systems.
Regulatory submissions have been managed by Biologics Consulting Group, Inc. and Biologics Consulting.
FDA 510(k) Regulatory Record - Mindray Bio-Medical Electronics Co., Ltd.
2 devices