New Industries Biomedical secures Hemolumi H6 device approval

Shenzhen New Industries Biomedical Engineering Co., Ltd. obtained a medical device registration certificate from the Guangdong Provincial Medical Products Administration for its Hemolumi H6 Automatic Coagulation Analyzer.

The Class II device uses coagulation, chromogenic substrate, and immunoturbidimetric methods for in-vitro detection of analytes in human plasma samples, including coagulation, anticoagulation, fibrinolysis, and antifibrinolysis functions.

The company expects no significant immediate effect on production, operations, or financial performance.