FIRN SARL

FIRN SARL specializes in mobility and support devices designed to assist individuals with limited mobility. Their product range includes quadriplegic wheelchairs (such as the FAUTEUIL QUADRICEPS STANDARD and PREMIUM), modular seating systems like the MODUL EXCEL E1 and MODUL DUO variants, vertical panels with adjustable advancement (e.g., PANNEAU VERTICAL AVEC AVANCE), and walkway systems including handrails with flooring for both adults and children (e.g., BARRES DE MARCHE 3 M and 4 M AVEC PLANCHER). These devices are intended to enhance independence and safety for users.

FIRN SARL is based in France and operates within the European regulatory framework. Their devices are designed to comply with the EU Medical Device Regulation (MDR), specifically falling under Class I classification. This classification means their products are subject to essential safety and performance requirements but do not require additional conformity assessments beyond general controls, as they pose minimal risk.

Yes, FIRN SARL’s devices are registered in the eudamed database, the official EU portal for medical device information. Registration in eudamed demonstrates compliance with EU regulatory obligations, including traceability and transparency requirements. This listing allows healthcare professionals, regulators, and patients to verify the manufacturer’s identity, device details, and regulatory status, ensuring accountability and trust in the supply chain.

All of FIRN SARL’s listed devices fall under Class I classification per the EU Medical Device Regulation. This classification is assigned based on risk assessment criteria—Class I devices are generally considered low-risk and do not require pre-market clinical evaluations or Notified Body involvement beyond basic manufacturing controls. However, they must still meet essential requirements for safety, performance, and proper labeling to ensure patient and user safety.