Kossel is pleased to announce a major regulatory milestone. Its peripheral interventional device portfolio has obtained EU CE‑MDR certification, granting official European market access and marking a key step in the company’s global expansion.

All four newly‑certified devices are independently developed in‑house by Kossel: Falspeed® PTA Balloon Dilatation Catheter, Falexpand® HP PTA Balloon Dilatation Catheter, Tanghulu® PTA Peripheral Balloon Dilatation Catheter, and Giranel® Guiding Sheath Set. Together, they form a complete peripheral interventional product portfolio for overseas markets.

Alongside previously CE‑MDR‑approved coronary products including the Selethru® PTCA Balloon Dilatation Catheter and Seledora® Coronary Scoring Balloon Catheter, these offerings create dual‑track peripheral‑coronary pipelines. This fuels execution of Kossel’s global strategy and delivers one‑stop endovascular interventional solutions covering diverse clinical scenarios and lesion types.

Guided by its global strategy “Local Base, Global Reach”, Kossel has built manufacturing facilities in Europe and Southeast Asia, with branch offices in Japan and other regions. The company competes globally through strong product value, robust quality‑management systems and full regulatory compliance.
These latest CE‑MDR approvals further strengthen Kossel’s international brand footprint, enabling high‑quality Chinese‑manufactured medical devices to benefit more patients worldwide.