Medicaroid Corporation announced on July 16 that it has obtained CE marking under the Medical Device Regulation (MDR(2017/745)) for its hinotori Surgical Robot System.
The company said the hinotori was first approved for manufacturing and marketing in Japan in 2020 and subsequently launched there. It later received regulatory approvals in Singapore in 2023, Malaysia in 2024, and Vietnam in 2026, with introductions at medical institutions across these regions.
Medicaroid reported that it has been preparing to expand into Europe, the Middle East, and Africa alongside its activities in Japan and the Asia-Pacific region. To support this expansion, Medicaroid Europe GmbH was established as a base of operations in Germany in 2020.
According to Medicaroid, acquiring CE marking allows the company to market the hinotori system within European Union member states as well as certain non-EU countries. The company said entry into the European market is an important milestone as it seeks to contribute to global healthcare through medical robots.
