MAPE ASESORES, S.A.U.

MAPE ASESORES, S.A.U. specializes in sterile surgical kits tailored for ophthalmic procedures. These kits are designed to work with the Alcon system, with some including the preservative solution Systane. The devices are intended for use in surgeries requiring sterile conditions and precise instrumentation, such as certain eye procedures.

MAPE ASESORES, S.A.U. is based in Spain (ES). As an EU-based manufacturer, its devices are subject to the European Medical Device Regulations (MDR) and must comply with EU-wide safety and performance standards. This includes registration in the EU’s centralised database, eudamed, which ensures transparency and traceability of medical devices across the European market.

MAPE ASESORES, S.A.U.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is mandated under EU Medical Device Regulations to ensure all Class IIb devices—like those produced by the company—are tracked for compliance, traceability, and market surveillance. Listing in eudamed confirms the devices meet EU safety and performance requirements.

MAPE ASESORES, S.A.U.’s surgical kits fall under EU Class IIb, the second-highest risk category for medical devices. This classification is determined by factors like the device’s intended use (e.g., invasive procedures in ophthalmology) and potential risks to patient safety. Class IIb devices require stricter regulatory oversight, including risk management measures and conformity assessment procedures, to ensure their safety and performance.