Core Viewpoint - Shengxiang Bio has recently obtained three product certifications and registrations, including two Class III medical device registrations in China and one CE IVDR certification in the European Union [2] Group 1 - Shengxiang Bio announced the acquisition of two Class III medical device registration certificates from the National Medical Products Administration [2] - The company also received a CE IVDR certification, which is essential for marketing medical devices in the European market [2]

Core Insights - Shengxiang Bio (688289.SH) has recently obtained three product certifications and registrations, including two Class III medical device registrations and one EU CE IVDR certification [1][2] - The newly launched products include a Norovirus nucleic acid detection kit and a combined detection kit for A group rotavirus, Norovirus, and F group enteric adenovirus, which will enhance the rapid identification and precise diagnosis of diarrheal pathogens [1] - The EB virus detection kit has received EU CE IVDR certification, expanding the company's herpes virus testing product line and demonstrating compliance with international quality and technical standards [2] Product Certifications - The company received the following certifications: - Norovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402188 [1] - A group rotavirus/Norovirus/F group enteric adenovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402226 [1] - EB virus nucleic acid detection kit (fluorescent PCR method), registration number: No.V120745520012Rev.00 [1] Market Impact - The introduction of the Norovirus and combined detection kits is expected to significantly improve clinical capabilities in identifying diarrheal pathogens, particularly benefiting vulnerable populations such as children and the elderly [1] - The EB virus is commonly associated with various diseases, including infectious mononucleosis and several types of cancer, highlighting the importance of the newly certified detection kit in public health [2] - The company aims to accelerate the global rollout of innovative products, contributing to public health and precision medicine [2]

证券代码：688289 证券简称：圣湘生物 公告编号：2025-070 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 圣湘生物科技股份有限公司（以下简称"公司"）于近日获得三项产品认证及注册， 其中两项为国家三类医疗器械注册证，一项为欧盟 CE IVDR 认证，现将相关情况公 告如下： 一、产品注册相关情况 | 注 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 册 人 | 注册 | | 注册证编 | 产品名称 | 预期用途 | 注册证有 | | 名 | 类别 | | 号 | | | 效期 | | 称 | | | | | | | | | | | | | 本试剂盒用于定性检测人粪 | | | | | | 国 械 注 准 | 诺如病毒核酸检测试 | 便 样 品 中 的 诺 如 病 毒 | | | | | | | 剂 盒 (PCR- 荧 光 探 针 | | 2030 ...

圣湘生物科技股份有限公司 2025 年第四次临时股东会会议资料 二〇二五年十一月 | | | 圣湘生物科技股份有限公司（688289）2025 年第四次临时股东会会议资料 2025 年第四次临时股东会会议须知 为了维护全体股东的合法权益，确保股东会的正常秩序和议事效率，保证会 议的顺利进行，根据《中华人民共和国公司法》（以下简称"《公司法》"）《中 华人民共和国证券法》（以下简称"《证券法》"）《上市公司股东会规则》以及 《圣湘生物科技股份有限公司章程》（以下简称"《公司章程》"）《圣湘生物科 技股份有限公司股东会议事规则》等相关规定，圣湘生物科技股份有限公司（以 下简称"公司"或"圣湘生物"）特制定 2025 年第四次临时股东会会议须知： 一、为保证股东会的严肃性和正常秩序，切实维护股东的合法权益，出席会 议的股东及股东代理人须在会议召开前 15 分钟到会议现场办理签到手续，并请 按规定出示身份证明文件或企业营业执照/注册证书复印件（加盖公章）、授权 委托书等，经验证后领取会议资料，方可出席会议。会议开始后，会议登记应当 终止，由会议主持人宣布现场出席会议的股东和代理人人数及所持有的表决权数 量。 二、会议 ...

Core Insights - Shengxiang Bio (688289.SH) has recently obtained three product certifications and registrations, including two Class III medical device registrations and one EU CE IVDR certification [1][2] - The newly launched products include a Norovirus nucleic acid detection kit and a combined detection kit for A group rotavirus, Norovirus, and F group enteric adenovirus, which will enhance rapid identification and precise diagnosis of diarrheal pathogens [1] - The EB virus nucleic acid detection kit has received EU CE IVDR certification, expanding the company's herpes virus testing product line and demonstrating compliance with international quality and technical standards [2] Product Certifications - The products certified include: - Norovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402188 - A group rotavirus/Norovirus/F group enteric adenovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402226 - EB virus nucleic acid detection kit (fluorescent PCR method), registration number: No.V120745520012Rev.00 [1] Market Impact - The introduction of these products is expected to significantly improve clinical capabilities in diagnosing diarrheal pathogens, particularly benefiting vulnerable populations such as children and the elderly [1] - The EB virus is commonly associated with various diseases, including infectious mononucleosis and several types of cancer, highlighting the importance of the newly certified detection kit in public health [2] - The company aims to accelerate the global rollout of innovative products, contributing to public health and precision medicine [2]

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]

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]

Core Viewpoint - The company plans to establish a partnership fund with a target fundraising scale of 1 billion yuan, focusing on investments in AI medical applications and innovative pharmaceuticals and medical devices [1] Group 1: Fund Details - The company will contribute 370 million yuan, representing a 37% stake in the fund [1] - The fund will not be included in the company's consolidated financial statements, limiting the risk exposure to the amount contributed [1] - The proposal will be reviewed and voted on at the temporary shareholders' meeting scheduled for November 17, 2025 [1]

圣湘生物公告，公司近日获得三项产品认证及注册，其中两项为国家三类医疗器械注册证，一项为欧盟 CE IVDR 认证。 ...

Core Insights - A new company, Changsha Shengwei Tongjia Biotechnology Co., Ltd., has been established, focusing on the production and sales of medical devices and human genetic diagnosis and treatment technology development [1] Company Overview - The legal representative of the newly established company is Dai Liqun [1] - The company is wholly owned by Shengxiang Biology (688289) through indirect holdings [1] Business Scope - The business scope includes the production of Class II and Class III medical devices, as well as the sales of Class II medical devices [1] - The company is also involved in the development of human genetic diagnosis and treatment technologies [1]