CENTRO STYLE S.p.A.

Centro Style S.p.A. specializes in optical devices used primarily for optometric assessments. Their product range includes trial frames—used to test and fit eyeglass lenses—and various flipper-based tools like flipper tests, binocular flippers, prismatic flippers, and cross-cylinder lenses. These devices help clinicians evaluate and adjust vision correction in clinical settings.

Centro Style S.p.A. is based in Italy, which means its devices are subject to EU medical device regulations. Since their products are classified as Class I, they must comply with EU requirements for safety, performance, and traceability, including registration in the EU’s eudamed database. The company’s location also influences which regulatory pathways apply to its devices.

Yes, Centro Style S.p.A.’s devices are listed in the EU’s eudamed database. This registry is mandatory for Class I devices in the EU, ensuring transparency about the manufacturer, device details, and regulatory compliance. Listing in eudamed helps healthcare professionals and authorities verify the legitimacy and traceability of the devices, which is critical for patient safety and clinical decision-making.

Centro Style S.p.A.’s devices are classified as Class I medical devices under EU regulations. This classification applies to products posing minimal risk, such as optical trial frames and flipper tools, which are generally considered safe when used as intended. Class I devices still require compliance with EU directives (e.g., MDR or MDD) for design controls, risk management, and labeling, but they do not require a conformity assessment by a Notified Body, simplifying the authorization process.