Tianxing Medical (01609): Obtained EU MDR certification and multiple overseas market product registration approvals

Zhitong Finance App News, Tianxing Healthcare (01609) issued an announcement. Recently, the company received the EU New Medical Device Regulation (CE MDR) certification certificate, making it the first sports medicine manufacturer in China to obtain CE MDR certification for all products. The products covered by the above certificate include full-stitched anchors, full-stitched multi-needle meniscus, metal strip anchors, polyether ether ketone wire anchors, carbon fiber composite wire anchors, polyether ether ketone sheath fixing systems, titanium plates, non-absorbent surgical stitches, U-shaped nails/portal nails, disposable planing heads, plasma surgery equipment, disposable radiofrequency plasma surgery electrodes, disposable arthroscopic cannulas, arthroscopic surgical instruments, etc. The above products include implants, active equipment and active equipment. Consumables and endoscopic surgical instruments can be used for shoulder, knee, hip, elbow, wrist, The six major foot and ankle joints provide overall clinical solutions.

At the same time, applications for registration of plasma surgery equipment, electrodes, full suture anchors, suture products, etc. submitted by the company in the United Kingdom, Australia, Brazil, Singapore, Malaysia, Thailand and other countries have been approved one after another, and registration certificates issued by the local competent authorities have been obtained.

The acquisition of the above certification and registration certificates indicates that more of our products meet the regulatory requirements of the European Union and the above countries, which will help the company further expand its overseas business layout in the European Union, Latin America and Southeast Asia, and further enhance the company's competitiveness and product layout in the international market.