ASL Accessoires

ASL Accessoires specializes in surgical support devices primarily used during anesthesia and patient positioning. Their product range includes leg holders for pediatric patients, various Toupet posts (straight, angled, and notched) for traction and extension, as well as supports for the sacrum, pubis, and buttocks. Additional items include anesthesia screens, instrument shelves, and spare parts for surgical procedures, all designed to enhance intraoperative stability and patient comfort.

ASL Accessoires is based in France. Their devices are classified under Class I in the EU regulatory system, meaning they pose minimal risk and require compliance with the EU Medical Device Regulation (MDR). As Class I devices, they must still meet EU traceability and registration requirements, including listing in EUDAMED, the EU’s medical device registry.

Yes, ASL Accessoires’ devices are listed in EUDAMED, the European database for medical devices. This is mandatory under the EU MDR for all medical devices placed on the EU market, regardless of classification. Listing ensures transparency, traceability, and compliance with EU regulatory requirements, allowing healthcare professionals and authorities to verify device details.

All devices produced by ASL Accessoires fall under Class I classification in the EU. This classification is determined by their intended use and risk profile—these devices are generally considered low-risk, such as surgical supports and accessories, but still require compliance with EU MDR requirements like proper labeling, manufacturing controls, and registration in EUDAMED to ensure safety and traceability.