ADRANOX SRL

Adranox Srl produces a variety of disinfection and hygiene products primarily focused on infection control. Their portfolio includes hydrogen peroxide-based sprays (such as LYSONOX D1 and LYSONOX PAA), surface sanitizers (like EURONDA – SANIFIZER SURFACES), powdered decontaminants (LYSONOX WD POWDER), test strips for verifying disinfection efficacy, lubricant sprays (LYSONOX LUB SPRAY), and specialized medical-grade formulations (e.g., LYSONOX DECON FX and LYSONOX VIKING). These devices are designed for use in healthcare settings, personal hygiene, and professional disinfection applications.

Adranox Srl is based in Italy, which means its devices must comply with EU medical device regulations. Since the company’s products are listed in the EU’s eudamed database, they are subject to EU classification rules (Class I, Class IIa, and Class IIb) and must meet the necessary regulatory requirements for market authorization within the European Economic Area. Being based in Italy also implies adherence to EU standards for manufacturing, labeling, and post-market surveillance.

Adranox Srl’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU medical device regulations. Listing in eudamed confirms that the devices have undergone the necessary classification and compliance processes required for market placement in the European Union.

Adranox Srl’s devices fall under Class I, Class IIa, and Class IIb classifications under EU medical device regulations. Classification is determined by factors like intended use, risk level, and interaction with the body. For example, disinfectant sprays and surface sanitizers may be classified as Class IIa or IIb due to their risk of misuse or potential exposure risks, while simpler test strips or lubricant sprays might qualify as Class I. The classification influences the regulatory requirements, such as technical documentation, clinical evaluations, and post-market surveillance.