LONGFIAN Attains MDR CE Certification

LONGFIAN is delighted to announce that we have officially been granted the CE certificate under EU Medical Device Regulation (MDR) 2017/745 after thorough review by an authorized EU Notified Body.

This certification confirms that our medical devices fully satisfy the strict safety, risk control, clinical and traceability standards of the updated EU medical device regulation. The achievement reflects our persistent focus on product safety and quality excellence, enabling us to legally distribute our products to all European Union and EEA member states.

Supported by our professional regulatory and quality teams, we have fully upgraded our quality management system, technical documentation and post-market surveillance system to meet all MDR compliance criteria. This certification strengthens our global market layout and empowers us to provide compliant, high-standard medical devices for European clients.

We will keep abiding by international medical device rules, sustain strict quality supervision, and strive to deliver premium medical solutions to partners worldwide.