Easy Medibot Completes “Ubot” Prototype, Begins Product Approval Testing Process

WSI subsidiary Easy Medibot has completed a review prototype of “Ubot,” a uterine-elevation robot for gynecological surgery, and begun the product approval process with the Ministry of Food and Drug Safety.

According to Easy Medibot on November 3, the prototype brings Ubot, previously introduced through rendered images, to life as actual equipment. On September 23, the company submitted a request for electrical and mechanical safety testing to the Korea Testing & Research Institute (KTR), and it will deliver two prototypes by November 6. A usability assessment will be conducted in parallel at the Medical Device Research and Development Center of Seoul National University Bundang Hospital.

Ubot is a robot developed to automate uterine elevation—the task of adjusting the position and angle of the uterus—during gynecological laparoscopic surgery. It is designed to allow surgeons to control the position of the uterus directly, and the company has secured related core patents in South Korea, the United States, and Europe.

Based on the test results, the company plans to pursue domestic product approval from the Ministry of Food and Drug Safety and an international certificate under the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE). It will also prepare for U.S. Food and Drug Administration (FDA) regulatory approval and certification under Europe’s Medical Device Regulation (CE). An Easy Medibot official said, “We will carry out safety and usability verification procedures and prepare for regulatory approvals in South Korea and abroad.”

This content was produced with the assistance of AI translation services.