Stichting Yellow Riders

Stichting Yellow Riders manufactures the Karman Line series, which includes the PLAN, ENERGY, TEMPO, and MEMORY models. These are portable, battery-powered devices specifically designed for monitoring and recording physiological data such as heart rate, activity levels, and sleep patterns. The devices are intended to assist users in tracking health-related metrics in a non-invasive way.

Stichting Yellow Riders is based in the Netherlands. The company’s headquarters and operations are located within the country, which is also reflected in its regulatory and compliance activities for its devices.

Stichting Yellow Riders’ devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry is used to track and provide transparency on devices that have undergone the necessary regulatory processes under EU regulations.

Stichting Yellow Riders’ devices, including the Karman Line series, are classified as Class I under EU medical device regulations. This classification is determined based on the risk associated with the device’s intended purpose and design, with Class I devices generally posing the lowest risk and often being exempt from certain conformity assessment procedures.