Shanghai, China - On June 19th, Shanghai Microport MedBot (Group) Co.,Ltd. (hereinafter referred to as "MicroPort® MedBot®") successfully obtained CE certification from the European Union for its DFVision® 3D Electronic Laparoscope (hereinafter referred to as "DFVision®"). With this achievement, DFVision® becomes the Chinese-developed 3D electronic laparoscope that has obtained both NMPA approval and CE certification in the European Union.

蜻蜓眼®此次完成的是欧盟医疗器械法规（Regulation (EU) 2017/745，简称MDR）的认证程序。MDR是欧盟针对医疗器械领域的一项新法规，与过去的MDD（Medical Device Directive，医疗器械指令）相比，MDR更侧重于器械的临床表现、更好的医疗器械可追溯性和更高的患者透明度，对于医疗器械进入欧盟市场的准入要求更加严格，对制造商、进口商和分销商以及公告机构的要求也有所加强。

 The certification process completed by DFVision® is in accordance with the European Medical Device Regulation (Regulation (EU) 2017/745, referred to as MDR). MDR is a new regulation in the European Union for the medical device field. Compared to the previous Medical Device Directive (MDD), MDR focuses more on the clinical performance of the device, better traceability of medical devices, and higher patient transparency. It imposes stricter requirements for market access of medical devices in the European Union and strengthens the requirements for manufacturers, importers, distributors, and notified bodies.

蜻蜓眼®用于腔镜手术的术中探查和成像，对腹腔及胸腔等器官进行观察、诊断、摄影或治疗。它具备高规格的光学指标，镜体本身更轻，同时兼容腔镜手术机器人平台，通过应用高分辨率成像物镜和电子镜结构，实现双路图像全高清呈现，为术者提供手术视野的三维立体感和手术操作的纵深感，能够满足临床高精细度、高立体层次的解剖需求，对手术中精准的游离、缝合和打结具有重要意义，可减少手术时间、降低手术失误、改善手术质量、提高手术效率，突破传统二维腹腔镜手术的局限性，适用于泌尿外科、普外科、胸外科、妇科等多科室手术。

DFVision® is used for intraoperative exploration and imaging in endoscopic surgery, allowing for observation, diagnosis, photography, or treatment of organs in the abdominal and thoracic cavities. It features high-quality optical specifications, a lighter body, and compatibility with endoscopic surgical robot platforms. By using high-resolution imaging objectives and an electronic laparoscope structure, it achieves dual-channel full HD presentation, providing surgeons with a three-dimensional sense of the surgical field of view and depth perception for surgical operations. It meets the clinical demand for high precision and anatomical detail, playing an important role in precise dissection, suturing, and knotting during surgery. It can reduce surgical time, decrease surgical errors, improve surgical quality, and enhance surgical efficiency. It breaks through the limitations of traditional two-dimensional laparoscopic surgery and is applicable to various departments such as urology, general surgery, thoracic surgery, and gynecology.

微创®机器人常务副总裁兼首席商务官刘雨先生：“相比传统腹腔镜，蜻蜓眼®更加贴近和满足医生手术的需求。自国内获批后，此次获得欧盟CE的认证，是对产品安全性的再次肯定。未来微创®机器人会通过临床应用，服务医患群体，让国产先进医疗器械在临床转化中发挥最大价值，践行‘让天下没有难做的手术’的初心。”

Mr. Liu Yu, Executive Vice President and Chief Commercial Officer of MicroPort® MedBot®, said, "Compared to traditional laparoscopy, DFVision® is closer to and meets the surgical needs of doctors. After obtaining NMPA approval, obtaining CE certification from the European Union reaffirms the safety of the product. In the future, MicroPort® MedBot® will serve the medical community through clinical applications, allowing domestically advanced medical devices to maximize their value in clinical transformation and fulfill the initial mission of 'Make Surgery Easier, Safer and Less Invasive.'."