赛诺医疗(688108.SH)：子公司产品获得欧盟 CE MDR 认证

Core Viewpoint - The company has successfully obtained EU CE MDR certification for its Ghunter intracranial thrombectomy stent, marking its first overseas registration for a self-developed product, which enhances its market competitiveness and operational prospects [1][2]. Group 1: Product Development and Certification - The Ghunter intracranial thrombectomy stent is a self-developed acute ischemic product by the company's subsidiary, featuring full visibility design, curled design for better wall adherence, and various mesh sizes to improve thrombosis engagement [1]. - The product received the Medical Device Registration Certificate from the National Medical Products Administration of China in April 2023 and subsequently obtained EU CE MDR certification in February 2026 [1]. Group 2: Market Impact and Quality Management - The approval signifies that the subsidiary has established a quality management system compliant with EU MDR regulations, allowing the stent to meet the latest market entry conditions in the EU and other regions recognizing EU medical device regulations [2]. - This certification is expected to positively impact the promotion and sales of the company's products in relevant markets, thereby enhancing the company's market competitiveness and future business operations [2].