Although the KANGDUO® SR2000 obtained CE marking under the EU MDR in December 2025, 2026 has marked its transition from regulatory clearance to actual European introduction. The first European clinical procedures were performed in Poland in May 2026, followed by further clinical use and structured training activities across Central and Eastern Europe. The system is currently CE marked for minimally invasive procedures in urology, gynecology, general and thoracic surgery; ENT and head and neck surgery are not included in its current European intended use.
J Granell. Oct 8, 2026