Medicaroid has received CE marking under the European Union’s Medical Device Regulation (MDR 2017/745) for its hinotori Surgical Robot System, enabling the company to market the robotic surgery platform across EU member states and selected non-EU countries.
The approval marks a significant step in Medicaroid’s international expansion strategy as it seeks to grow beyond its established markets in Japan and the Asia-Pacific region.
The hinotori Surgical Robot System was first approved for manufacture and sale in Japan in 2020 before being launched domestically.
Since then, the system has secured regulatory approvals in Singapore in 2023, Malaysia in 2024 and Vietnam in 2026, supporting its rollout across hospitals in the region.
Alongside its Asia-Pacific expansion, Medicaroid has been preparing to enter the Europe, Middle East and Africa (EMEA) market. The company established Medicaroid Europe GmbH in Germany in 2020 to support commercial operations across the region.
With CE marking now in place, Medicaroid can begin marketing the hinotori Surgical Robot System throughout the European Union and in certain other countries that recognize the certification.
The company said entry into the European market represents an important milestone in its efforts to expand the global adoption of medical robotics and support healthcare providers with advanced surgical technologies.
Medicaroid said it remains committed to contributing to healthcare through medical robotics while supporting better outcomes for patients and healthcare professionals.
