Recently, Falspeed® PTA Balloon Dilatation Catheter and Falexpand® HP PTA Balloon Dilatation Catheter, two independently developed products by Kossel Medtech, have officially secured registration certification from the Department of Health of the Hong Kong Special Administrative Region (HKSAR), granting approval for marketing and sales in Hong Kong.

As an Asian hub for medical innovation and a key platform for international medical technology exchange, Hong Kong SAR operates the MDACS registration framework renowned for stringent international standards. Specifically, Class III medical devices are subject to rigorous audits covering safety, clinical efficacy and quality management systems prior to registration.

Previously, Falspeed® PTA Balloon Dilatation Catheter and Falexpand® HP PTA Balloon Dilatation Catheter have successively obtained approvals including the U.S. FDA clearance and Brazil’s ANVISA certification. The latest Hong Kong SAR registration represents another landmark milestone in the Company’s internationalization strategy. It expands Kossel Medtech’s portfolio of peripheral interventional devices to cover core Asia-Pacific markets, delivering a diversified range of treatment options for clinicians in Hong Kong SAR.

Leveraging the geographic and policy strengths of the Guangdong-Hong Kong-Macao Greater Bay Area in the years ahead, Kossel Medtech will further deepen collaboration with medical institutions across Hong Kong SAR. The Company aims to elevate regional diagnosis and treatment standards for peripheral vascular diseases, advance the implementation of the Healthy China Initiative, and strengthen integrated cooperation and service capabilities under the Belt and Road Initiative for healthcare collaboration.