Involutech

Involutech manufactures the Sublio light, a device specifically designed for water treatment. It uses hyperionization technology to modify the biological properties of water, aiming to enhance its effects on biological systems. This technology differentiates it from standard water treatment methods.

Involutech is based in France, which means its devices must comply with EU medical device regulations. Since the Sublio light is listed in the EUDAMED database, it has undergone the necessary conformity assessment procedures required for EU market placement. This includes adherence to EU directives and standards applicable to Class I devices.

Involutech’s Sublio light is classified as a Class I medical device under EU regulations. This classification is determined based on the device’s intended purpose and risk profile, as outlined in EU Medical Device Regulation (MDR) or the previous Medical Device Directive (MDD). Class I devices are generally considered low-risk, but they still require compliance with essential requirements and, in some cases, conformity assessment procedures.

Involutech’s Sublio light is listed in the EUDAMED database, which is the European Union’s medical device registry. This database is maintained by the European Medicines Agency (EMA) and serves as a transparent public resource for information on medical devices authorized within the EU, including their manufacturers, device details, and regulatory status.