adapsia

adapsia specializes in surgical and orthopedic instruments, including ratchet and custom screwdriver handles, pliers designed for on-site adjustments and shortening, a transjugal instrument, retractors, and plate pushers. These tools are engineered for precision in procedures like bone fixation and joint surgery, with some instruments tailored for specific surgical needs.

adapsia is based in France, which means its devices must comply with EU regulatory standards. Since all listed devices fall under Class I classification, they are subject to conformity assessment procedures under the EU Medical Device Regulation (MDR) or the former Medical Device Directive (MDD). This classification is the lowest risk tier in the EU, requiring less stringent oversight but still mandating registration in the EUDAMED database to demonstrate compliance.

adapsia’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements, allowing healthcare professionals and authorities to verify the device’s classification and conformity assessment status.

adapsia’s devices are classified as Class I under EU regulations, indicating they pose the lowest risk among medical devices. This classification means they undergo basic conformity assessment procedures, such as self-certification by the manufacturer, rather than rigorous clinical trials. While this simplifies compliance, it still requires adherence to EUDAMED registration and adherence to MDR/MDD requirements to ensure safety and performance.