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Toumai® Surgical Robotic System Receives EU CE MDR Certification for Robot-Assisted Telesurgery
2026-06-22 GMT+8 PM 03:09

[Shanghai, China] – June 17, 2026 — MicroPort® MedBot™ announced that the Toumai® surgical robotic system has received CE certification under the European Union Medical Device Regulation (MDR) for robot-assisted telesurgical procedures in urology, general surgery, thoracic surgery, and gynecology.

 

The certification confirms that the Toumai® system meets the applicable requirements of the EU Medical Device Regulation for its intended use and establishes a regulatory foundation for the clinical adoption of robot-assisted telesurgery across Europe.

 

 

 

 

Where the necessary technical infrastructure is available, the certification enables specialist surgeons to provide remote surgical assistance or perform procedures from geographically distant locations. The technology has the potential to expand access to specialised surgical expertise, strengthen collaboration between healthcare institutions, and support new models of surgical education, mentoring, and clinical proctoring across national borders.

 

The system's telesurgery capabilities have already been demonstrated through initial intra-European procedures performed between ORSI Academy in Melle and AZORG Hospital in Aalst, Belgium, providing early clinical experience with cross-site robotic surgery under the European regulatory framework.

 

The CE MDR certification represents an important milestone in the continued development of robotic-assisted telesurgery and supports broader adoption of connected surgical care throughout Europe. MicroPort® MedBot™ will continue collaborating with clinical partners to advance safe, effective, and accessible robotic surgery worldwide.

 

 

 

 

About MicroPort® MedBot™

Commenced development of laparoscopic surgical robots in 2014 and officially established in Shanghai in 2015, Shanghai MicroPort MedBot (Group) Co., Ltd. ("MicroPort® MedBot™", stock code: 02252.HK), a subsidiary of MicroPort Scientific Corporation ("MicroPort®", stock code: 00853.HK), is currently the only surgical robotics company with businesses spanning five major segments: laparoscopic, orthopedic, vascular interventional, natural orifice, and percutaneous surgical robotics.

MicroPort® MedBot™ integrates robotics, intelligent control, image-guided navigation, and precision imaging technologies to develop intelligent surgical solutions that support minimally invasive care worldwide.

 

Regulatory Disclaimer

The Toumai® surgical robotic system has received CE marking under the European Union Medical Device Regulation (MDR) for robot-assisted telesurgical procedures in urology, general surgery, thoracic surgery, and gynecology. Regulatory approvals and cleared indications vary by country and region. Healthcare professionals should consult applicable local regulatory requirements and the product instructions for use.

 

References

  1. CE MDR certification documentation – Data on file, MicroPort® MedBot™.
  2. Supporting technical documentation for the approved telesurgical indications – Data on file, MicroPort® MedBot™.
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