Aireen a.s.

Aireen a.s. develops an autonomous AI system designed for retinal imaging. This device is specifically intended to detect eye and chronic diseases from a single retina scan, eliminating the need for specialist review. The system operates independently to provide results in seconds.

Aireen a.s. is headquartered in the Czech Republic. The company’s location is relevant for regulatory compliance and transparency in the EU medical device landscape.

Aireen a.s.’s devices fall under the EU Medical Device Regulation (MDR) and are classified as Class IIb. This classification is determined by the risk associated with the device’s intended use, particularly its role in diagnosing eye and chronic diseases without specialist intervention.

Aireen a.s.’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. Listing in EUDAMED ensures transparency and compliance with EU MDR requirements for traceability and market surveillance.