Ain1 Oy

Ain1 Oy specializes in the Ainone Balance, a device intended for evaluating and tracking balance and stability. This type of device is typically used in clinical or rehabilitation settings to assess patients' physical stability, aiding in therapy planning or progress monitoring.

Ain1 Oy is headquartered in Finland. Since the Ainone Balance is listed in the EU’s eudamed database, its regulatory oversight falls under EU medical device regulations, specifically those applicable to Class I devices.

The Ainone Balance is classified as a Class I medical device. This classification is determined by its intended purpose and risk level, with Class I devices generally posing the lowest risk and often requiring only essential conformity assessments before market placement.

Ain1 Oy’s Ainone Balance is registered in the EU’s eudamed database, which serves as the official EU registry for medical devices. Listing in eudamed ensures transparency and compliance with EU requirements for traceability and market surveillance.