STAR SPORTS MED (01609): Obtained EU MDR certification and multiple overseas market product registration approvals.
Tianxing Medical (01609) announced that it has recently received the certification for the new EU Medical Device Regulation (CE MDR), becoming the first sports medicine manufacturer in China to obtain CE MDR certification for its entire product line.
STAR SPORTS MED (01609) announced that the company has recently received the certification for the new European Union medical device regulations (CE MDR), making it the first sports medicine manufacturer in China to obtain CE MDR certification for its full line of products. The aforementioned certification covers products including all-suture anchor, all-suture loop plate, continuous suture multi-needle meniscus, metal tape suture anchor, polyether ether ketone tape suture anchor, carbon fiber composite tape suture anchor, polyether ether ketone nail sheath fixation system, loop titanium plate, non-absorbable surgical suture, U-shaped nails/gate-shaped nails, single-use resection blade heads, plasma surgical equipment, single-use radiofrequency plasma surgical electrodes, single-use arthroscopy cannulas, and arthroscopic surgical instruments, totaling 15 categories of products. These products include implants, active devices, consumables, and endoscopic surgical instruments, providing integrated clinical solutions for six major joints: shoulder, knee, hip, elbow, wrist, and ankle.
At the same time, the company's registration applications for plasma surgical equipment and electrodes, all-suture anchors, and suture-related products submitted in countries such as the United Kingdom, Australia, Brazil, Singapore, Malaysia, and Thailand have also been approved, and the certificates have been issued by the local regulatory authorities.
The acquisition of the above certification and registration certificates signifies that more of the company's products comply with the regulatory requirements of the European Union and the aforementioned countries, facilitating the companys further expansion of its overseas business layout in Europe, Latin America, and Southeast Asia, and enhancing its competitiveness and product positioning in the international market.
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