Saints Sages SA100 Earns CE-MDR Certification, Pioneering China’s First Dual 7mm Energy Platform for Global Markets

The CE-MDR approval marks a major milestone in Saints Sages’ international expansion, showcasing China’s leadership in high-end surgical energy systems combining ultrasonic and advanced bipolar technologies.

1. Breaking Through to Overseas Markets

The SA100 System is a high-end energy platform product independently developed by Saints Sages Surgical, which obtained the NMPA Class III medical device registration certificate in March this year. Adopting advanced technology, the system boasts high efficiency, safety and reliability, and can be widely applied in general surgery, obstetrics and gynecology, urology and other fields. Following the SA10 product's acquisition of the CE registration certificate last year and the FDA registration certificate this year, this is another international recognition for Saints Sages Surgical. It is also the first energy platform product that features both an ultrasonic scalpel and advanced bipolar functionality with 7mm coagulation effect to enter the international market.

2. Technological Breakthroughs

The advanced bipolar accessory of the SA100 System is an important component, integrating multiple functions such as 7mm large blood vessel coagulation, cutting and grasping, which can greatly improve surgical efficiency and safety. This accessory adopts cutting-edge 7mm large blood vessel coagulation technology and is equipped with an advanced MPTS algorithm, enabling precise control of energy output, reducing tissue damage, shortening surgical time and lowering surgical risks. Meanwhile, the 7mm ultrasonic scalpel equipped in the system also performs excellently. Relying on the independently developed RTTE II intelligent algorithm of Saints Sages Surgical, it can dynamically identify tissue types and states, realizing millisecond-level adaptive adjustment of output energy. While ensuring cutting performance, it effectively controls thermal damage and significantly improves surgical precision and safety. The acquisition of CE-MDR certification for the SA100 System this time is not only a reflection of the product's strength, but also a vivid practice of Chinese enterprises responding to the national "14th Five-Year Plan for the Development of the Medical Equipment Industry" and promoting the independent controllability and overseas innovation of high-end medical equipment. Driven by the policies of "Healthy China 2030" and "Made in China 2025", domestic medical device enterprises are gradually transforming from technology followers to standard setters. As an innovative representative in the field of energy surgery, Saints Sages Surgical breakthrough in international authoritative certification for its SA100 System has injected strong confidence into China's high-end medical equipment's entry into the global high-end market.

3. Industrial Leap Forward
Industry analysis points out that within less than a year, Saints Sages Surgical has successively obtained the FDA registration for the SA10 product and the CE-MDR certification for the SA100 System, demonstrating the enterprise's solid R&D accumulation and efficient execution. The advanced bipolar accessory equipped in the SA100 System integrates the cutting-edge MPTS algorithm, achieving performance benchmarking against international top-tier products in terms of technical capabilities. As a leading product in the global large blood vessel closure field, advanced bipolar has completed over 35 million surgeries since its launch 25 years ago, occupying 78% of the U.S. market and approximately 50%-60% of the European market, with its safety and effectiveness supported by more than 1,300 clinical studies. The key technical indicators of the SA100 advanced bipolar accessory of Saints Sages Surgical have reached the international leading level. At the same time, its 7mm ultrasonic scalpel, relying on the precise energy control of the RTTE II intelligent algorithm, is expected to form a unique advantage in the field of laparoscopic surgery that emphasizes fine anatomy, providing better energy surgery solutions for global clinical institutions. The successive overseas launches of such high-end energy platforms will not only help shape the technical brand image of "Intelligent Manufacturing in China" in the global surgical equipment field, but also mark that domestic medical devices have gained the strength to compete with international giants on the same stage in the field of high-end energy surgery, providing a replicable innovation model for China's medical device industry to transform from a market giant to a technology power.

Looking forward to the future, Saints Sages Surgical stated that it will continue to increase R&D investment, deepen cooperation with global clinical experts, expand the international market with more innovative products with independent intellectual property rights, and enable more high-end medical solutions innovated in China to benefit doctors and patients around the world.