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]