Bionime Corporation’s next-generation iFree2 Continuous Glucose Monitoring (CGM) System has officially obtained certification under the European Union Medical Device Regulation (EU MDR). This certification confirms that the product meets the EU’s stringent requirements for medical device quality, safety, clinical performance, and risk management, representing another significant milestone in Bionime’s international expansion and laying a solid foundation for growth across Europe and other global markets.

The iFree2 CGM System is Bionime’s latest continuous glucose monitoring solution, featuring up to 15 days wearing, a sensor approximately 50% smaller than the previous generation, calibration free  that eliminates the need for daily fingerstick calibration while keep fingerstick calibration optional.

As the global CGM market continues to grow, Bionime has been actively expanding its international presence. The company has established partnerships with distributors and business partners across Asia-Pacific, the Middle East, Latin America, and Europe. Moving forward, Bionime will continue to accelerate global market expansion through a dual strategy of its own brand and CDMO (Contract Development and Manufacturing Organization) services.

Obtaining EU MDR certification marks a key milestone in the global commercialization of the iFree2 CGM System. Bionime will continue to advance market access, scale up manufacturing and product delivery, and strengthen international collaborations to further expand its global footprint and enhance its competitiveness in the international medical device market.