元化智能一年内获12张医疗器械注册证 骨科手术机器人实现全链条自主突破

Core Insights - Yuanhua Intelligent Technology (Shenzhen) Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its robotic knee surgery system "YuanBOT-HX200," marking a significant milestone in its product development and regulatory achievements [1][2] - The company has obtained a total of 12 registrations in 2025, covering surgical robots, intelligent software, supporting consumables, and rehabilitation monitoring equipment, indicating a robust product portfolio [1] - Yuanhua Intelligent aims to penetrate the global market, showcasing its capabilities in high-end specialized medical equipment innovation and precision manufacturing [1] Company Developments - Established in 2018, Yuanhua Intelligent focuses on the innovative research and development of high-end specialized medical equipment, particularly in orthopedic surgical robots [1] - The company has developed a comprehensive product layout that includes advanced surgical robots for multiple clinical applications, becoming the only domestic company with the capability to independently develop all core components of orthopedic surgical robots [1] - At the 2025 Shenzhen International High-Performance Medical Device Expo, Yuanhua Intelligent showcased a groundbreaking "five-in-one" surgical robot that can assist in hip, knee, unicompartmental, spinal, and trauma surgeries, emphasizing the intelligent, digital, and information-driven nature of modern surgical procedures [2] Industry Impact - The registration certificates obtained by Yuanhua Intelligent serve as official recognition and market entry approval in the medical field, reflecting the company's strong R&D capabilities and the advancement of China's AI robotics industry [2] - The collaboration with the National Clinical Center for research and clinical trials highlights the company's systematic layout and continuous innovation in the field of orthopedic intelligent diagnosis and treatment [2] - The achievements of Yuanhua Intelligent signify that high-end medical equipment manufacturing in China has gained international recognition, marking a significant step forward in the industry [2]