STAR SPORTS MED (01609.HK): First Chinese Sports Medicine Manufacturer with Full Product Line EU CE MDR Certified

NewTimeSpace News: On 10 September 2026, Beijing Star Sports Medicine Co., Ltd. (stock code: 01609) announced in a voluntary filing that the company has recently received the EU Medical Device Regulation (CE MDR) certification, becoming the first Chinese sports medicine manufacturer to obtain full product line CE MDR certification. The certification covers 15 product categories including all-suture anchors, all-suture button plates, metal and PEEK suture anchors, arthroscopic surgical instruments, plasma surgical devices and single-use electrodes, providing integrated clinical solutions for the shoulder, knee, hip, elbow, wrist and foot/ankle.

In parallel, the company's registration applications for plasma surgical devices and electrodes, all-suture anchors and suture products in the United Kingdom, Australia, Brazil, Singapore, Malaysia and Thailand have been successively approved, with local regulatory certificates obtained. The company said the certifications and registrations indicate that more of its products meet the regulatory requirements of the EU and the aforementioned countries, supporting the further expansion of its overseas business presence in the EU, Latin America and Southeast Asia.

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