The "Orthopedic Surgery Simulation Software" independently developed by Huida Kaide (Beijing) Medical Technology Co., Ltd. (hereinafter referred to as "Huida Kaide"), an enterprise in the Beijing Sino-German Industrial Park, has officially received the Class III Medical Device Registration Certificate issued by the National Medical Products Administration (NMPA), marking a successful start to the new year.

Huida Kaide's Orthopedic Surgery Simulation Software is fully compatible with DICOM-standard X-ray and CT images. It features 2D visualization, 3D reconstruction, and other functions, assisting in the planning of hip and knee joint replacements and spinal fusion surgeries. The software enables precise preoperative planning, intraoperative navigation, and postoperative remote monitoring. This approval signifies that Huida Kaide has overcome challenges in image processing and simulation algorithms, successfully expanding into the domestic market. In the future, Huida Kaide will increase its investment in research and development, launching innovative products such as web versions and digital operating rooms integrated with virtual reality glasses, providing stronger support for addressing clinical challenges and improving healthcare service quality.

About Huida Kaide (Beijing) Medical Technology Co., Ltd.

Huida Kaide (Beijing) Medical Technology Co., Ltd. was registered and established in the Beijing Sino-German Industrial Park in 2023. It is a joint venture between mediCAD, a hidden champion in Germany's digital orthopedic software field, and Beijing Thunderbird Technology Co., Ltd., a professional software supplier in China's healthcare sector. The company focuses on the R&D, production, and sales of medical software for orthopedic surgery planning. As a key enterprise in the pharmaceutical and health sector of the Beijing Sino-German Industrial Park, Huida Kaide is dedicated to providing precise digital orthopedic solutions, aiming to improve human bone health, enhance quality of life, and build a mutually beneficial value system connecting patients, medical institutions, and researchers.

Moving forward, the Beijing Sino-German Industrial Park will continue to leverage its resource advantages to provide comprehensive service support to enterprises within the park, further enhancing service quality and standards, and assisting enterprises in achieving higher-quality development.

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The Class III certificate is the highest level of medical device registration certification, issued by the National Medical Products Administration (NMPA). Medical devices are classified into three categories: Class I, Class II, and Class III. Class III medical devices directly contact the human body or are even implanted, used to support or sustain life. They carry high risks and require special measures for strict control and management to ensure their safety and effectiveness. Consequently, the regulatory standards for obtaining this certification are stringent, the approval process is complex, and clinical trial requirements are high.