Another Breakthrough in Global Expansion! EndoFresh® Single-Use Gastrointestinal Endoscopy System Achieves EU MDR Certification

This milestone confirms that our product quality and compliance systems meet the stringent requirements of the EU Medical Device Regulation (MDR), granting EndoFresh® a market-access “passport” for Europe!

 

 

The EU Medical Device Regulation is widely regarded as one of the world’s most stringent market-access frameworks for medical devices. Its certification process is lengthy and involves broad, rigorous assessment across multiple dimensions, making it highly recognized throughout the industry. This certification demonstrates that the safety, effectiveness, and performance of the EndoFresh® Single-Use Gastrointestinal Endoscopy System meet the stringent requirements of the EU MDR. It also underscores the company’s research and development capabilities and quality-control system while further strengthening the product’s global competitiveness.

 

Guided by the principle of **“one patient, one scope, dispose after use,”** EndoFresh® adopts a single-use design that addresses at source the risk of cross-contamination associated with reuse and reprocessing. It provides a safer and more efficient clinical option for emergency care, bedside procedures, patients with infectious diseases, and surgical procedures with stringent sterility requirements.

 

 

Standing at a new starting point and embarking on a new journey, obtaining the MDR certificate represents not only recognition, but also greater responsibility.

 

Looking ahead, Daichuan Medical will continue to uphold its **patient-centered and innovation-driven** philosophy, continuously optimize its product portfolio, and harness Chinese technology and intelligent manufacturing to deliver higher-quality, safer, and more convenient single-use endoscopy solutions to healthcare institutions and patients worldwide.