BEIEN-SURG’s Full Range of Ultrasonic Devices Secures EU MDR Certification

All BEIEN-SURG ultrasonic surgical devices have successfully obtained certification under the EU Medical Device Regulation (MDR, EU 2017/745). The certified portfolio includes the 7 mm integrated ultrasonic scalpel, the 5 mm integrated ultrasonic scalpel, and the 5 mm modular ultrasonic scalpel, confirming that all BEIEN-SURG ultrasonic products meet the EU’s latest regulatory requirements.

Recognized as one of the most stringent medical device regulatory frameworks globally, the MDR places strong emphasis on product safety, quality management, and clinical performance. The successful certification of BEIEN-SURG’s full ultrasonic portfolio demonstrates the company’s commitment to reliable product quality and robust regulatory compliance, and supports the continued expansion of its ultrasonic solutions in the European and other international markets.