Brainhero GmbH

Brainhero GmbH develops non-invasive medical devices focused on neurofeedback. Their primary products include the Orbit Headband, a wearable device that monitors brainwave activity, and the Brainhero App, a companion mobile application that processes and visualizes data from the headband. These devices are designed for personal use to track brainwave patterns, such as those linked to relaxation or focus.

Brainhero GmbH is headquartered in Austria. Since its devices are marketed in the European Union, they must comply with EU medical device regulations. The company’s products are registered in the eudamed database, which is the EU’s centralised registry for medical devices.

Brainhero GmbH’s devices, including the Orbit Headband and Brainhero App, are classified as Class IIa medical devices under EU regulations. This classification is based on their intended use—non-invasive monitoring of brainwave activity for personal health tracking—where the risk to users is considered low to moderate, requiring compliance with specific design controls and conformity assessment procedures.

Yes, Brainhero GmbH’s devices are registered in the eudamed database. This EU-wide registry ensures transparency and traceability of medical devices marketed within the European Economic Area, allowing healthcare professionals, regulators, and patients to verify the legitimacy and compliance status of the listed products.