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 announcement highlights that Sino Medical Technology Co., Ltd.'s subsidiary, Sino Shenchang Medical Technology Co., Ltd., has received EU CE MDR certification for its Ghunter intracranial thrombectomy stent, marking a significant milestone for the company in entering the European market [2][5]. Group 1: Certification Details - The Ghunter intracranial thrombectomy stent was registered under the EU Medical Devices Regulation (EU) 2017/745 and has received the EU CE MDR certification [2]. - The product is designed for the removal of thrombus in large vessels of ischemic stroke patients within 24 hours of symptom onset, and it is a single-use device with a shelf life of 2 years [3][4]. - The certification includes an EU Quality Management System Certificate and an EU Technical Documentation Assessment Certificate, with the certificate issued on February 18, 2026, and expiring on February 1, 2031 [4]. Group 2: Product Features - The Ghunter stent features a full visualization design for improved surgical visibility, a curled design for better wall adherence and thrombosis capture, and various mesh sizes to enhance its ability to capture different types of thrombus [4]. - The product has already received a medical device registration certificate from the National Medical Products Administration of China in April 2023 [4]. Group 3: Impact on the Company - The certification signifies that Sino 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 [5]. - This approval is expected to positively impact the promotion and sales of the company's products in relevant markets, enhancing the company's market competitiveness and future operations [5].