Sino Medical Sciences Technology Inc. (688108.SH) has announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., submitted application materials in 2024 to a European Union notified body for the registration of its Ghunter intracranial thrombectomy stent under the EU Medical Devices Regulation (MDR) (EU) 2017/745. The subsidiary recently received notification from the EU notified body that the Ghunter intracranial thrombectomy stent has obtained EU CE MDR certification.

This marks the first overseas registration certification for a product independently developed by Sino Shenchang, indicating that the subsidiary has established a quality management system compliant with EU MDR requirements. The certified intracranial thrombectomy stent meets the standards of EU medical device regulations, qualifies for the latest market access conditions in the European Union, and can be sold in regions recognizing EU medical device regulations.

The approval is expected to positively impact the promotion and sales of the company's products in relevant markets, enhance the market competitiveness of its products, and contribute favorably to future business operations.