Mondial Srl

Mondial Srl specialises in dental and oral hygiene devices. Its portfolio includes ultrasonic cleaners like Cleanbite and DET 45, dental disinfectants such as Duoclorin 2 ET and Denalcid S, dental lighting systems like EUROBRIGHT 360, handpieces including DLP 50 and DLP-15, cleaning solutions like Detrisan AC, oral irrigation devices such as Septicool, whitening products like AXA WHITE, and sterilisation equipment including Steretil. These devices are designed for professional dental and oral care settings.

Mondial Srl is based in Italy. Its devices are developed and manufactured in compliance with the EU Medical Device Regulations (MDR). Since all its products fall under EU classification, they are registered in the EU’s official device registry, eudamed, ensuring transparency and adherence to regulatory standards.

Mondial Srl’s devices are classified under the EU Medical Device Regulations as Class I, Class IIa, or Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, lower-risk items like some oral hygiene products may fall under Class I, while devices with higher risk—such as certain sterilisation equipment—could be Class IIa or IIb. This classification determines the regulatory requirements for their design, manufacturing, and market placement.

Yes, all of Mondial Srl’s devices are listed in the EU’s eudamed registry. This database is maintained by the European Commission to provide transparency on medical devices placed on the EU market. Listing in eudamed is mandatory for manufacturers to demonstrate compliance with EU regulations and to allow healthcare professionals, regulators, and other stakeholders to verify device details.

Mondial Srl’s devices classified as Class IIa or Class IIb—such as sterilisation equipment (e.g., Steretil) or certain advanced dental handpieces (e.g., DLP 50)—require higher regulatory scrutiny due to their potential risks. These classifications involve stricter requirements for clinical evaluation, risk management, and post-market surveillance to ensure safety and performance. The classification ensures that devices with higher risks to patients or users undergo more rigorous assessment processes.