三诺生物:取得四项医疗器械注册证

Core Viewpoint - The company has received four medical device registration certificates from the Hunan Provincial Drug Administration, indicating regulatory approval for new and existing products [1] Group 1: New Product Approval - The new product, a blood glucose, uric acid, and ketone analyzer, has been registered with the certificate number 湘械注准20252220980, valid until December 7, 2030 [1] - This analyzer is designed for quantitative detection of glucose, uric acid, and β-hydroxybutyrate concentrations in various blood samples, including fresh capillary whole blood, venous whole blood, arterial whole blood, and neonatal whole blood [1] Group 2: Continuation of Existing Products - The company has also received continuation registrations for blood glucose test strips and test kits for apolipoprotein A1, apolipoprotein B, creatine kinase, and creatine kinase MB isoenzyme using immunoturbidimetric and rate methods [1]