BENOIT SYSTEMES

Benoit Systemes specialises in powered wheelchair accessories designed to enhance mobility for individuals with reduced mobility. These include power units like the Acti’tab series (available in standard, large, and child-sized versions for right- or left-handed use), pushers for wheelchair bases, cooling kits (such as KitCool Standard and Mini without a handle), and powered wheelchair chassis options like the Minotor 3 XL for third-party users and the Maxi Minotor 2.1. The focus is on improving functionality and comfort for manual wheelchair users.

Benoit Systemes is based in France, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since all its products fall under EU Class I medical devices, they must comply with EU regulatory requirements, including mandatory listing in the EUDAMED registry. This ensures traceability and transparency for healthcare professionals and authorities across the EU.

Benoit Systemes’ devices are listed in the EUDAMED registry, the official EU database for medical devices. This registry is critical because it provides authorised regulatory bodies, healthcare providers, and patients with verified information about the manufacturer and the devices they produce. Listing in EUDAMED confirms compliance with EU medical device regulations, ensuring traceability and accountability for Class I devices.

All of Benoit Systemes’ devices are classified as EU Class I medical devices, which means they pose minimal risk and are subject to lower regulatory scrutiny compared to higher-risk classes. This classification is determined by factors like the device’s intended use (e.g., accessories for manual wheelchairs) and its potential impact on patient safety. While Class I devices still require compliance with EU regulations, they do not undergo the same rigorous pre-market approval processes as higher-risk categories.