赛诺医疗科学技术股份有限公司 关于子公司产品获得欧盟CE MDR认证的公告

Core Viewpoint - The company, Sainuo Medical Technology Co., Ltd., has successfully obtained the EU CE MDR certification for its Ghunter intracranial thrombectomy stent, marking its first overseas registration certification for a self-developed product [1][3]. Group 1: Product Registration and Certification - The Ghunter intracranial thrombectomy stent has been registered with the EU announcement agency under the EU Medical Devices Regulation (EU) 2017/745 [1]. - The product received the EU CE MDR certification, which includes the EU Quality Management System Certificate and the EU Technical Documentation Assessment Certificate [1][3]. - The certification was issued on February 18, 2026, and is valid until February 1, 2031 [3]. Group 2: Product Specifications and Usage - The Ghunter stent is designed for the removal of thrombus in large intracranial vessels of ischemic stroke patients within 24 hours of symptom onset [2]. - The stent features a full visualization design, curled design for better wall adherence, and various mesh sizes to enhance thrombus capture capabilities [3]. Group 3: Impact on the Company - The certification signifies that Sainuo Shenchang has established a quality management system compliant with EU MDR requirements, allowing the stent to meet the latest market entry conditions in the EU [3]. - This approval is expected to positively influence the promotion and sales of the company's products in relevant markets, enhancing market competitiveness and future business operations [3].