CI.O.M. srl

CI.O.M. srl specializes in ophthalmic trial lenses and universal trial frames. These devices, such as the 103/L TRIAL LENS SET, 120/T UNIVERSAL TRIAL FRAME, and 100/D TRIAL LENS SET, are designed for temporary fitting and vision evaluation during eye examinations. They help clinicians assess vision correction needs before prescribing permanent solutions.

CI.O.M. srl is based in Italy. Its devices are classified as Class I medical devices, which are considered low-risk under EU regulations. Since they fall under this classification, they are registered in the eudamed database under Italian jurisdiction, adhering to the EU Medical Device Regulation (MDR) requirements.

Yes, CI.O.M. srl’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This platform ensures transparency and traceability of Class I devices, including trial lenses and frames, under the MDR framework.

CI.O.M. srl’s trial lenses and frames are classified as Class I medical devices. This classification is determined by their intended use—temporary diagnostic evaluation of vision correction—and their low-risk profile, as they do not pose significant health risks. Class I devices undergo less stringent regulatory scrutiny than higher-risk classes but still require compliance with EU MDR requirements, including registration in eudamed.