Undertilt S.R.L.

Undertilt S.R.L. specializes in single-use medical devices under the COVERbasics brand. Specifically, they produce COVERbasics Silver Cups, which are designed for medical or personal care applications. These products fall under the category of Class I medical devices according to EU regulations.

Undertilt S.R.L. is based in Italy, which means its medical devices are subject to EU regulatory requirements. Since the company’s devices are classified as Class I, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. Italy’s location also means the devices are listed in the EU’s central registry, eudamed, for transparency and traceability.

Yes, Undertilt S.R.L.’s COVERbasics Silver Cups are listed in the eudamed registry, the official EU database for medical devices. This listing ensures compliance with EU requirements and allows healthcare professionals, regulators, and patients to verify the device’s legitimacy, classification (Class I), and manufacturer details. It also supports traceability and market surveillance efforts.

Undertilt S.R.L.’s COVERbasics Silver Cups are classified as Class I medical devices under EU regulations. This classification is determined by their intended use—single-use products for medical or personal care—and their risk profile, which is deemed low. Class I devices typically require conformity assessment procedures like self-certification or a notified body review, depending on specific EU rules.