美康生物(300439.SZ)：控股子公司取得医疗器械注册证

Core Viewpoint - Meikang Biotech (300439.SZ) has obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the Jiangxi Provincial Drug Administration, enhancing its product line in the field of chemiluminescence diagnostics and positively impacting its core competitiveness and market expansion capabilities [1]. Group 1: Product Registration Details - The registered product is a complex of tissue-type plasminogen activator-inhibitor 1 detection reagent, valid from September 15, 2025, to September 14, 2030, used for quantitative measurement of t-PAIC concentration in human plasma, aiding in the diagnosis of cardiovascular diseases and disseminated intravascular coagulation [2]. - Another registered product is the thrombin-antithrombin complex detection reagent, also valid from September 15, 2025, to September 14, 2030, used for assessing coagulation activation status and assisting in the diagnosis of thrombotic diseases [2]. - The company has also registered a thrombomodulin detection reagent, valid for the same period, which is used for quantitative measurement of TM concentration in human plasma, assisting in the diagnosis of endothelial cell injury [2]. - Additionally, a detection reagent for plasmin-α2-plasmin inhibitor complex has been registered, with the same validity period, aimed at assisting in the diagnosis of thrombotic diseases [2].