赛诺医疗(688108.SH)：Ghunter颅内取栓支架产品获得欧盟CE MDR认证

Core Viewpoint - Sino Medical (688108.SH) announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., has submitted registration materials for the Ghunter intracranial thrombectomy stent to the EU Notified Body under the Medical Devices Regulation (EU) 2017/745, and has received CE MDR certification, marking the first overseas registration for a self-developed product [1] Group 1 - The Ghunter intracranial thrombectomy stent has obtained CE MDR certification according to EU regulations [1] - This certification indicates that Sino Shenchang has established a quality management system compliant with EU MDR requirements [1] - The product can now be sold in regions that recognize EU medical device regulations, enhancing its market competitiveness [1] Group 2 - The approval is expected to positively impact the promotion and sales of the company's products in the relevant markets [1] - This development will contribute to the company's future operations and overall business performance [1]