Medicaroid Corporation has announced that the CE marking under the Medical Device Regulation (MDR(2017/745)) has been obtained for the hinotori Surgical Robot System.
The hinotori was originally approved for manufacturing and marketing in Japan in 2020 and subsequently launched domestically. After that, it received regulatory approvals in Singapore in 2023 and Malaysia in 2024, and has been introduced at medical institutions across these regions. It also received regulatory approval in Vietnam in 2026.
In parallel with advancing the business in Japan and the Asia-Pacific region, Medicaroid has been preparing for expansion into Europe, the Middle East, and Africa (EMEA). To support this initiative, Medicaroid Europe GmbH was established in Germany in 2020 as a base of operations.
With the acquisition of CE marking, Medicaroid says it is now able to market the hinotori in EU member states as well as certain non-EU countries. Entry into the European market represents a significant milestone for Medicaroid in continuing to contribute to global healthcare through medical robots.
