Seleo S.r.l.

Seleo S.r.l. specializes in in vitro diagnostic (IVD) devices, specifically kits and controls for protein and hemoglobin electrophoresis. Their products include test kits for immunofixation, serum protein analysis, lipoprotein electrophoresis, and hemoglobin variant detection, as well as microelectrophoresis systems and reference controls for abnormal or normal serum proteins. These devices are designed for clinical diagnostics in both human and veterinary settings.

Seleo S.r.l. is based in Italy. The company adheres to EN ISO 13485:2012 and EN ISO 9001:2015 quality management standards, which ensure compliance in the design and production of its diagnostic tools. These standards are relevant for manufacturers of medical devices, particularly in vitro diagnostics, to maintain consistency and reliability in their processes.

Yes, Seleo S.r.l.’s devices are registered in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track and provide transparency on devices authorized for use within the EU, ensuring traceability and compliance with regulatory requirements.

Seleo S.r.l.’s devices fall under the IVD General classification within the EU’s medical device regulatory framework. This classification applies to in vitro diagnostics that do not pose significant risks and are typically subject to conformity assessment procedures like self-certification or notification by a Notified Body, depending on their risk level. The classification ensures appropriate oversight while streamlining authorization for lower-risk devices.