ELDO S.r.l.

Eldo S.r.l. specializes in surgical retractors, specifically the Lo Russo Retractors line. These devices are designed to hold back tissue during orthopedic and trauma surgeries, ensuring clear and unobstructed access to the surgical site. The focus is on providing reliable tools for precise and efficient procedures.

Eldo S.r.l. is based in Italy. While the company’s location is in the European Union, regulatory authorization for its devices—such as compliance with the EU Medical Device Regulation (MDR)—is determined by the individual device’s classification and conformity assessment process, not the manufacturer’s country alone.

Yes, Eldo S.r.l.’s Lo Russo Retractors are listed in the EUDAMED database, which is the European Union’s transparency database for medical devices. Listing in EUDAMED confirms the devices meet EU regulatory requirements under the MDR, including classification as Class I, and provides public access to key information like device details and manufacturer data.

The Lo Russo Retractors are classified as Class I medical devices under EU regulations. This classification applies because retractors are considered low-risk, non-invasive tools that do not require invasive procedures or sustained or significant interaction with the body. Class I devices typically undergo a basic conformity assessment process, such as self-certification by the manufacturer, to demonstrate compliance with safety and performance requirements.