Workflow
A组轮状病毒/诺如病毒/F组肠道腺病毒三联检
icon
Search documents
圣湘生物产品取得医疗器械注册证及欧盟CE认证
Zhi Tong Cai Jing· 2025-11-07 10:12
Core Viewpoint - Shengxiang Bio (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 [1] - The newly launched products include a Norovirus single test and a triple test for Group A Rotavirus/Norovirus/Group F Enterovirus, aimed at improving rapid identification and precise diagnosis of diarrhea pathogens [1] Group 2: Market Impact - The new products are expected to significantly bolster the clinical diagnosis capabilities for key demographics, particularly children and the elderly, thereby strengthening intestinal health defenses in these vulnerable 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 indicate that the company's products meet stringent international standards in quality, technical performance, and management systems [1] - This achievement is a significant milestone in the company's molecular diagnostics strategy and internationalization efforts [1]