By Fineline Cube 
Shanghai-based Shanghai MicroPort EP MedTech Co., Ltd. (SHA: 688351) announced on July 23, 2025, that its self-developed IceMagic balloon cryoablation catheter has received EU Medical Device Regulation (MDR 2017/745) certification. The product is indicated for the cryoablation treatment of atrial fibrillation. The certificate, numbered MDR 754792 R000, was issued by BSI and is valid until July 15, 2030.
Significance of Certification
This latest certification means all components of the IceMagic cryoablation system have now obtained EU MDR approval. This milestone marks the formal entry of the company’s cryoablation product line into the international market.
Global Market Strategy
The company stated that this certification will help facilitate the synergistic deployment of its “radiofrequency + cryoablation” products overseas. It will also enhance global brand recognition and support the company’s expansion in international markets.-Fineline Info & Tech