ETABLISSEMENTS OURY GUYE ET FILS

Etablissements Oury Guyé et Fils specialises in reusable orthopaedic surgical instruments. Their portfolio includes general internal orthopaedic fixation system implantation kits, self-retaining and hand-held retractors, retraction system mounting frames, bone hooks, implant inserters/extractors, and manual bone files/rasps and curettes. These tools are designed to assist in orthopaedic procedures such as bone preparation, retraction, and implant placement.

The company is based in France. This European location allows them to comply with EU regulatory requirements, including device listing in the EU’s EUDAQS database (eudamed).

Devices from Etablissements Oury Guyé et Fils are listed in the EU’s EUDAQS database (eudamed) and the FDA’s Unique Device Identifier (UDI) system (fda_udi). Listing in these registries helps ensure traceability and compliance with regulatory requirements in both the European Union and the United States.

All devices produced by Etablissements Oury Guyé et Fils fall under Class I classification. Class I devices are generally considered low-risk, often involving general-purpose surgical instruments or accessories that do not present significant health risks when used as intended. This classification simplifies regulatory oversight while maintaining compliance with safety standards.