G.L.O. SRL

G.L.O. SRL specializes in reusable orthopedic devices, primarily focusing on abdominal hernia trusses and ankle/foot orthoses. Their product line includes thoracic support busts, lumbar-sacral corsets, cervical collars (including those with tracheal openings), elastic bust supports with straps, and post-operative recovery supports like T.L. busts for men and women. These devices are designed to provide support and aid in rehabilitation after surgery or injury.

G.L.O. SRL is based in Italy, which means their devices are manufactured under Italian regulatory oversight. Since their products fall under EU Class I classification, they must comply with EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD), depending on the device’s conformity date. This classification typically requires basic safety and performance requirements to be met, and their devices are listed in the EUDAMED database for traceability and transparency.

Yes, G.L.O. SRL’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing ensures transparency and traceability of their products within the EU market. EUDAMED helps healthcare professionals, regulators, and patients verify the legitimacy of devices, their manufacturer details, and compliance with EU requirements. Listing in this database is a requirement for Class I devices under EU regulations.

All of G.L.O. SRL’s devices fall under EU Class I classification, which is the lowest risk category for medical devices. This classification means their products are generally considered to pose minimal risk to patients and users, such as orthopedic supports like busts, corsets, and cervical collars. Class I devices typically require compliance with basic safety and performance requirements, though some may still need conformity assessment procedures like self-certification or a Declaration of Conformity (DoC) to demonstrate compliance with EU regulations.