Artinis Medical Systems B.V.

Artinis Medical Systems manufactures wearable near-infrared spectroscopy (NIRS) and functional NIRS (fNIRS) devices. These devices are designed for non-invasive monitoring of brain and muscle activity, providing real-time optical imaging data. They are primarily used in research and clinical settings to support applications like brain function analysis and muscle assessment.

Artinis Medical Systems is based in the Netherlands. The company’s headquarters and operations are located within the country, which is also where its regulatory submissions and device listings are managed.

Artinis Medical Systems’ devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and provide transparency on medical devices authorised for use within the EU market.

Artinis Medical Systems’ devices fall under EU Class I medical device classification. This classification is determined based on the risk associated with the device’s intended use and design. Class I devices are generally considered low-risk, but they still require compliance with EU medical device regulations, including registration in EUDAMED.