MONA.health

MONA.health develops wearable, non-invasive medical devices for remote patient monitoring. Specifically, the company produces the MONA DR, which tracks cardiac rhythm, and the MONA GLC, designed for continuous glucose monitoring to assist diabetes management. Both devices are engineered to collect real-time data for clinical oversight.

MONA.health is headquartered in Belgium, where it aligns its operations with EU medical device regulations. This includes compliance with the necessary requirements for device classification, registration, and market listing within the European Union.

MONA.health’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This platform ensures transparency and traceability of devices authorised for the European market, including their classification and regulatory status.

MONA.health’s devices fall under EU Class I classification. This classification is determined by factors like the device’s intended purpose, risk level, and interaction with the body. Class I devices are generally considered low-risk but still require compliance with EU directives to ensure safety and performance.