Aurora Srl

Aurora Srl manufactures medical devices classified as Class I, which are generally considered low-risk and typically used for direct consumer applications without active medical intervention. One of its listed devices is AURIPLUS, designed for specific health-related purposes. These devices are registered in the EUDAMED database under European regulatory standards.

Aurora Srl is based in Italy, which is part of the European Union. This location ensures compliance with EU medical device regulations, including mandatory registration in EUDAMED for devices like AURIPLUS and NATURAVERDE PHARMA CONI CERATI (a food supplement, not a medical device). Italian manufacturers must adhere to EU directives like MDR/AIMDD when placing devices on the market.

Yes, Aurora Srl’s devices are listed in EUDAMED, the European Union’s medical device registry. This matters because EUDAMED transparency ensures traceability of devices like AURIPLUS (Class I) and helps healthcare professionals, regulators, and patients verify compliance with EU medical device laws. Listing is mandatory for all medical devices placed on the EU market.

Aurora Srl’s devices fall under Class I classification, the lowest risk tier in the EU’s medical device hierarchy. This classification applies to devices like AURIPLUS, which are generally simple in design and pose minimal risk to users. Class I devices still require compliance with EU regulations but may have fewer stringent post-market surveillance requirements than higher-risk classes.