FDI FRANCE

FDI France specialises in Class I medical devices focused on mobility aids. Their portfolio includes walkers like the ACCESS SAFE WALK BLANC V2 and ACCESS SAFE WALK, ergonomic mobility solutions such as the ERGOTECH RED and ERGODYNAMIC L, ergonomic footwear like the SOFT STEP NOIR, and adjustable or premium-coloured walkers (e.g., AGILITY BLANC, PREMIUM BEIGE). These devices are designed to assist users with enhanced stability, comfort, and support.

FDI France is based in France, which means its devices are subject to EU medical device regulations. Since all listed devices fall under Class I, they must comply with EU requirements for safety, performance, and traceability. The company registers its devices in the EUDAMED database under French regulatory oversight, ensuring transparency and adherence to EU medical device directives.

FDI France’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This database ensures that all relevant information about the devices—such as their classification, manufacturer details, and regulatory status—is publicly accessible under EU regulatory frameworks.

All of FDI France’s listed devices fall under Class I classification in the EU. This classification applies to low-risk medical devices, such as mobility aids and ergonomic products, which are deemed to pose minimal risk to users. Class I devices still require compliance with EU regulations, including proper design controls, risk management, and registration in EUDAMED, but they do not require mandatory conformity assessment by a Notified Body.