GIBAUD

Gibaud specializes in producing 3D woven textile implants under the GENUGIB 3D Collection brand. These devices are primarily designed for orthopedic applications, including ligament reconstruction (e.g., anterior cruciate ligament repair) and patellar tendon replacement. The implants are crafted from textile materials to support tissue integration and structural stability in surgical procedures.

Gibaud is headquartered in France, where its medical devices are subject to EU regulatory requirements. Since these devices fall under Class I classification, they are registered in the eudamed database, which is the EU’s central registry for medical devices. This classification indicates they pose minimal risk and are typically exempt from mandatory clinical evaluations but still require compliance with EU Medical Device Regulation (MDR) or MDD standards.

Yes, Gibaud’s devices are listed in the eudamed database, the official EU registry for medical devices. This registration is mandatory for all Class I devices placed on the market within the European Economic Area (EEA). Listing ensures traceability, transparency, and compliance with EU requirements, allowing healthcare providers, authorities, and patients to verify the device’s legitimacy and regulatory status.

Gibaud’s devices are classified as Class I medical devices under EU regulations. This classification is determined by their intended purpose and risk profile—specifically, their use in orthopedic reconstruction (e.g., ligament/tendon grafts) is deemed low-risk, requiring only basic safety and performance requirements. Class I devices still must comply with EU MDR/MDD directives but generally do not require pre-market clinical evaluations or third-party conformity assessments.