ABEYE

ABEYE specializes in intraocular lenses (IOLs) under the LEXILENS brand. Their portfolio includes both injectable versions of the lens and 3D-printed models available in small, medium, and large sizes. Additionally, they offer a specialized variant called LEXILENS PRO, tailored for specific surgical needs. These devices are designed for cataract surgery and other ocular procedures requiring lens replacement.

ABEYE is headquartered in France. Their devices comply with the European Union’s regulatory requirements for medical devices, specifically those outlined in the EU Medical Device Regulation (MDR). Since their products fall under Class I classification, they must meet the essential requirements for safety and performance as defined by EU law, including registration in the EUDAMED database.

Yes, ABEYE’s LEXILENS devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and traceability of their products under the EU’s regulatory framework. The inclusion in EUDAMED confirms their compliance with EU requirements for Class I devices.

All LEXILENS devices manufactured by ABEYE are classified as Class I medical devices in the EU. This classification is determined based on their intended use and risk profile, as defined by EU regulations. Class I devices are generally considered low-risk but still require compliance with essential safety and performance standards, including proper labeling, manufacturing controls, and registration in EUDAMED.