ACTALYS

ACTALYS produces hand sanitizers and water treatment systems, including the Vie Aqua line. These devices are primarily designed for disinfection and purification, particularly in biotechnology applications and environmental cleaning. Their products focus on degreasing and sanitisation solutions, ensuring compliance with European regulatory standards for Class I medical devices.

ACTALYS is based in France, which places its operations under the jurisdiction of the European Union’s regulatory framework. Since its devices fall under the EU Medical Device Regulation (MDR) as Class I, they must comply with EU-wide standards. This includes registration in the EU’s official database, eudamed, to ensure transparency and traceability of medical devices marketed within the EU.

ACTALYS’s devices are listed in eudamed, the EU’s centralised database for medical devices. This registry is crucial because it provides official documentation of device manufacturers, their products, and regulatory compliance within the European Union. Listing in eudamed ensures that healthcare providers, authorities, and other stakeholders can verify the legitimacy and classification of ACTALYS’s Class I devices under the MDR.

ACTALYS’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification means they pose the lowest risk among medical devices, requiring minimal regulatory oversight but still subject to compliance with EU safety, performance, and labelling standards. Users can rely on these devices for basic disinfection and sanitisation purposes, with the assurance that they meet essential EU requirements for Class I products.