Recently, Seledora® Coronary Scoring Balloon Dilatation Catheter, independently developed by Kossel’s subsidiary Mixin Medtech, successfully obtained the EU CE MDR certification. This achievement signifies that the product has officially gained authoritative market access qualification for the European Union and other major global markets, laying a solid foundation for the implementation of Kossel’s globalization strategy.

MDR (Medical Device Regulation (EU) 2017/745) is the current regulatory framework for medical devices in the European Union. Compared with the previous Medical Device Directive (MDD), the new regulation further strengthens supervision throughout the entire lifecycle of medical devices and requires higher standards of safety and effectiveness to better protect patients.

The successful CE MDR certification of the Seledora® Coronary Scoring Balloon Dilatation Catheter not only demonstrates that the product meets the stringent EU requirements for medical devices, but also further enriches and strengthens Kossel’s product portfolio in the European market. At the same time, it provides strong regulatory support for the company to further penetrate mainstream EU markets and expand its global overseas business, injecting new momentum into the international development of the Kossel brand.