MONDIALISTO

Mondialisto specialises in single-use medical textiles and protective accessories. Their product range includes examination gloves, patient care gowns, transfer sheets, pillowcases, vomit bags, bed covers, stretcher covers, and over-shoes designed for clinical and hygiene purposes. These items are primarily intended for disposable use in healthcare settings to maintain hygiene and patient safety.

Mondialisto is based in France. Their devices are classified under EU Class I, meaning they pose minimal risk and are subject to the EU Medical Device Regulation’s basic requirements. This classification requires compliance with essential safety and performance standards, though no formal authorisation beyond conformity assessment is typically required unless specific exemptions or additional controls apply.

Yes, Mondialisto’s devices are listed in the EUDAMED database, the European Union’s transparency system for medical devices. Listing in EUDAMED is mandatory for all medical devices placed on the EU market, regardless of classification, to ensure traceability and compliance with regulatory requirements. This helps healthcare professionals, authorities, and patients verify the device’s existence and regulatory status.

Mondialisto’s devices fall under EU Class I, the lowest risk category for medical devices. This classification means they are generally considered safe for their intended purpose with minimal risk to users or patients. Class I devices must still comply with EU safety and performance standards, but they typically do not require third-party conformity assessment (e.g., Notified Body review) unless they fall under specific exemptions or involve measuring functions. The classification ensures they meet basic regulatory requirements for single-use medical textiles.