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圣湘生物科技股份有限公司 关于自愿披露相关产品取得医疗器械注册证及欧盟CE认证的公告
Group 1 - The company has recently obtained three product certifications and registrations, including two Class III medical device registrations in China and one EU CE IVDR certification [1] - The newly launched products, including a Norovirus single test and a tri-test for Group A Rotavirus/Norovirus/Group F Enterovirus, will significantly enhance the rapid identification and precise diagnosis of diarrheal pathogens, particularly benefiting vulnerable populations such as children and the elderly [1] Group 2 - The EB virus detection reagent has received EU CE IVDR certification, enriching the company's herpes virus testing product line and demonstrating compliance with international quality, technical performance, and management standards [2] - This achievement is a significant milestone in the company's molecular diagnostics strategy and internationalization efforts, aiming to contribute to global public health and precision medicine [2]
圣湘生物(688289.SH)产品取得医疗器械注册证及欧盟CE认证
智通财经网· 2025-11-07 10:12
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]