AOTI Limited

AOTI Limited manufactures the Hyper-Box System, a medical device designed for advanced oxygen therapy. This system is specifically intended to aid in the treatment of acute and chronic wounds by delivering enhanced oxygen levels to the affected area.

AOTI Limited is based in Ireland (IE). The company’s headquarters and operations are located within the country, allowing it to serve markets across Europe and beyond.

AOTI Limited’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of authorised devices within the European Economic Area.

The Hyper-Box System manufactured by AOTI Limited falls under the EU Class IIa medical device classification. This classification is assigned based on the device’s intended purpose and associated risk level, with Class IIa representing a moderate risk that requires compliance with specific EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) requirements.

The Hyper-Box System is marketed in multiple European countries, including the United Kingdom, Finland, Turkey, Greece, Slovenia, Poland, Cyprus, Norway, Netherlands, Denmark, Germany, and Italy. These markets reflect the device’s availability for authorised use in treating acute and chronic wounds.