圣湘生物(688289.SH)产品取得医疗器械注册证及欧盟CE认证

Core Viewpoint - Shengxiang Biotechnology (688289.SH) has recently obtained three product certifications and registrations, enhancing its diagnostic capabilities for viral pathogens associated with gastrointestinal diseases [1] Group 1: Product Certifications - The company received two Class III medical device registrations and one EU CEIVDR certification for its products [1] - The newly launched products include a Norovirus single test and a triple test for Group A Rotavirus/Norovirus/Group F Enteric Adenovirus, aimed at improving rapid identification and precise diagnosis of diarrhea pathogens [1] Group 2: Market Impact - The products are particularly beneficial for vulnerable populations such as children and the elderly, providing a robust defense for intestinal health in these groups [1] - The EB virus detection reagent has also received EU CEIVDR certification, expanding the company's herpes virus testing product line [1] Group 3: Strategic Importance - The certifications signify that the company's products meet international quality, technical performance, and management system standards, marking a significant achievement in its molecular diagnostics and internationalization strategies [1]