StoryRegulatory
Toumai receives EU CE MDR certification for robot-assisted telesurgery
Shanghai MicroPort MedBot Group Co., Ltd.Toumai
MicroPort MedBot announced that Toumai received CE certification under the EU Medical Device Regulation (MDR) for robot-assisted telesurgery in urology, general surgery, thoracic surgery and gynecology. The company positioned this as the first remote surgical robot to obtain CE marking under MDR.
- Certification covers four surgical specialties: urology, general, thoracic and gynecology
- Enables remote surgical procedures across distances up to 18,900 km
- Regulatory foundation established for European clinical adoption of robot-assisted telesurgery
- First CE MDR certification for telesurgery robotics from a Chinese manufacturer