SIMAD S.R.L.

Simad S.R.L. specializes in mobile radiology tables and x-ray systems tailored for intraoperative imaging. Their product line includes devices like the Moonray 500, Moonray Compact, and Moonray Dual, which are designed to support radiological procedures directly in operating rooms. These systems are engineered to provide adjustable architectures and precise imaging during surgery, ensuring real-time visualization for medical professionals.

Simad S.R.L. is based in Italy, which means its medical devices must comply with both European Union (EU) and U.S. regulatory requirements. In the EU, their devices are registered in the eudamed database, indicating they meet EU Medical Device Regulations (MDR) or previous directives. In the U.S., they are listed under FDA 510(k) submissions, demonstrating compliance with U.S. Food and Drug Administration (FDA) clearance processes for medical devices.

Simad S.R.L.’s devices are classified under Class I, Class II, and Class IIb categories. Classification depends on factors like risk level, intended use, and potential health impact. Class I devices pose the lowest risk (e.g., simple x-ray tables), while Class IIb devices involve higher risks (e.g., advanced intraoperative imaging systems) and require stricter regulatory scrutiny, such as clinical evaluations or performance standards. The classification determines the regulatory pathway and documentation requirements for market authorization.

Simad S.R.L.’s devices are listed in two key regulatory registries: eudamed (the EU’s medical device database) and the FDA’s 510(k) registry (for U.S. clearance). Inclusion in eudamed confirms compliance with EU Medical Device Regulations (MDR) or prior directives, while listing under 510(k) indicates that the devices have undergone FDA review and clearance for commercial distribution in the U.S. These registries serve as official records of authorized devices for transparency and traceability.