In 2026, EndoFresh® marks another heavy-weight breakthrough in its overseas layout on the global endoscopy map!
Recently, the single-use electronic gastroscope series (Models: XZING-W200B, DG-R300M, DG-T300S) independently developed by Daichuan Medical's brand, EndoFresh®, officially granted the Japanese Designated Managed Medical Device Manufacturing and Marketing Certification (Certificate No.: 308AFBZX00026000). Concurrently, the trademark "EndoFresh®" has also successfully completed its registration in Japan.
The dual issuance of the product certification and trademark registration signifies that we have officially obtained the regulatory passport to enter the Japanese medical device market, advancing our strategic layout in high-standard global markets.
一、Global Vision: The High-Standard Japanese Market
Japan maintains one of the most stringent regulatory entry barriers for medical devices worldwide, backed by world-leading endoscopic diagnostic systems and manufacturing standards. The certification process involves an extensive timeline and a comprehensive evaluation matrix, which encompasses:
- Product safety and efficacy
- Manufacturing Quality Management System - GMP
- Clinical risk control including image quality, maneuverability, and biocompatibility
- End-to-end regulatory compliance capability
Securing Japanese regulatory approval demonstrates that the products not only satisfy basic performance criteria but have also successfully passed systemic validation under an exceptionally high-standard clinical framework.This approval stands as another powerful testament to the innovative strength of China's precision medical devices on the global stage.
二、EndoFresh® Product Adaptability
The newly approved EndoFresh® single-use gastroscope series achieves high clinical adaptability across multiple key dimensions tailored to real-world healthcare needs:
Accessing Complex Anatomical Sites | Wide 210° Angulation Control
The ultra-wide bending angle allows for deep navigation into complex and tortuous areas such as the gastric fundus and duodenum. Within Japan's rigorous early cancer screening framework, this translates directly into higher lesion detection rates.
Integration of Diagnosis & Treatment | Large 3.8 / 4.2mm Working Channels
The large working channel design accommodates the simultaneous entry of various therapeutic accessories, balancing both examination and treatment. This mitigates the risk and burden of repeated hospital visits and anesthesia for elderly patients, aligning perfectly with Japan’s patient-centered, meticulous clinical philosophy.
High-Definition Visual Identification | 2-Megapixel HD Imaging
It precisely captures early-stage lesions and assists physicians in identifying subtle mucosal variations, perfectly matching the demands of Japan's refined early cancer screening.
Eradicating Cross-Infection at the Source | Single-Use Sterile Design
The "one scope per patient" model eliminates the need for reprocessing, disinfection, and specialized scope storage infrastructure. This significantly reduces capital expenditure, labor costs, and space constraints, effectively addressing the labor shortages faced by Japanese healthcare facilities.
As the challenge of multidrug-resistant organisms (MDROs) becomes increasingly prominent, the prevention and control of endoscopy-related infections have taken center stage in clinical focus. Geriatric patients with compromised immunity are particularly vulnerable to MDRO risks.
The EndoFresh® single-use endoscope delivers the highest tier of infection control for immunocompromised elderly patients while assisting Japanese medical institutions in lowering the risk of nosocomial MDRO outbreaks.
International Delphi Consensus:Single-use endoscopes are recommended for patients with known MDRO (multidrug-resistant organism) infections or colonization to eliminate the risk of cross-contamination.
三、 Intelligent Manufacturing in China, Moving Forward Non-Stop
From Europe and the Middle East to Japan, the international footprint of EndoFresh® continues to expand.
The progressive market adoption across diverse geographies reflects the brand's sustained refinement in product performance, quality management systems, and clinical adaptability.Every product certification and market access achievement marks an expansion of our commercial reach, as well as a consolidation of our technical depth.
On the stage of international exchange, EndoFresh® consistently participates in global dialogues—ranging from WCOG and UEGW to ESGE—actively integrating into the academic and clinical frameworks of the global gastroenterology field.
Moving forward, we will reinforce our brand moat through continuous innovation, dedicated to promoting more efficient, safer, and more comprehensive single-use endoscopy solutions worldwide.This is not only Daichuan Medical's answer to globalization, but our deep-rooted commitment to safeguarding human lives across the globe.