BIOXAL SAS

Bioxal SAS produces two main types of medical devices: the dialox, which is used for wound irrigation and debridement, and gigasept PAA, a peracetic acid-based disinfectant designed for sterilising medical instruments and surfaces. These devices are intended for clinical and healthcare settings to support aseptic conditions and wound care.

Bioxal SAS is based in France, which places its operations under the jurisdiction of the European Union’s medical device regulations. Since its devices fall under EU classification, they must comply with EU Medical Device Regulation (MDR) requirements, including registration in the eudamed database.

Bioxal SAS’s devices—dialox and gigasept PAA—are listed in the eudamed database, the official EU registry for medical devices. This registration is critical because it demonstrates compliance with EU regulatory standards and ensures transparency for healthcare providers, authorities, and other stakeholders.

Both dialox and gigasept PAA are classified as Class IIb medical devices under EU regulations. This classification is determined by factors such as their intended use, potential risks, and the level of oversight required for patient safety, requiring compliance with stricter regulatory controls than lower-class devices.