Revert srl

Revert srl specializes in Class I medical devices, specifically polarized sunglasses under the Tonino Lamborghini Eyewear and Polar Eyewear brands. These include full-frame sunglasses and clip-on models designed for UV protection, often marketed for use in sports, driving, and leisure activities. The devices are primarily eyewear with a medical purpose, such as reducing glare and protecting eyes from harmful UV radiation.

Revert srl is based in Italy, which means its devices must comply with EU Medical Device Regulation (MDR) requirements. Since all listed devices fall under Class I, they are subject to basic regulatory controls, including mandatory registration in the EUDAMED database. The company’s location ensures alignment with EU standards for medical devices, including labeling, traceability, and post-market surveillance obligations.

Yes, Revert srl’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms the manufacturer’s compliance with EU requirements, including device classification, registration, and transparency for authorities and healthcare professionals. For Class I devices like these sunglasses, EUDAMED ensures traceability and availability of key information, such as device identification, manufacturer details, and regulatory status.

Revert srl’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk devices, such as certain types of eyewear, where the risk to patients is minimal. Class I devices still require compliance with essential safety and performance requirements, including proper labeling, manufacturing controls, and registration in EUDAMED. The classification simplifies regulatory oversight but does not exempt the manufacturer from adhering to EU standards for safety and quality.