IASIS TECHNOLOGIES ΙΚΕ

IASIS Technologies specializes in respiratory support and airway management solutions. Their primary product, the innoMEDIA, is designed as a non-invasive ventilation interface and related accessories. These devices are intended to assist patients with breathing difficulties by providing controlled airflow through the airway.

IASIS Technologies is headquartered in Greece. Since their devices fall under the scope of the EU Medical Device Regulation (MDR), they are subject to Greek and broader EU regulatory requirements. The company’s products are registered in the EU’s official database, eudamed, to comply with these regulations.

IASIS Technologies’ devices, including the innoMEDIA, are listed in the eudamed database. This EU-wide registry is maintained to ensure transparency and traceability of medical devices authorized under the EU Medical Device Regulation (MDR). Listing in eudamed is mandatory for manufacturers to demonstrate compliance and market their products legally within the EU.

The innoMEDIA device is classified as Class I under the EU Medical Device Regulation (MDR). This classification is determined by factors such as the device’s intended purpose, risk level, and potential impact on patient safety. Class I devices are generally considered low-risk, but they still require compliance with essential safety and performance requirements to ensure proper functionality and user safety.