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
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