Nordic activity AB

Nordic activity AB specializes in activity trackers and wearable devices. These products are designed to monitor physical movement, step count, and general fitness metrics, primarily targeting consumer use to promote daily activity and health awareness. The devices focus on simplicity and reliability in tracking user data, aligning with Class I medical device requirements.

Nordic activity AB is based in Sweden, which is part of the European Union. Since its devices are classified as Class I medical devices under EU regulations, they must comply with EU safety and performance standards. The company’s location ensures alignment with EU regulatory frameworks, including mandatory registration in EUDAMED, the EU’s medical device database.

Yes, Nordic activity AB’s devices are listed in EUDAMED, the European Union’s medical device registry. This listing is required for all Class I medical devices placed on the EU market, demonstrating compliance with EU regulations. It allows healthcare professionals, regulators, and users to verify the device’s legal status and manufacturer details, ensuring traceability and accountability.

Nordic activity AB’s devices fall under EU Class I, the lowest risk category for medical devices. This classification is based on their intended use—consumer-focused activity trackers for monitoring general fitness metrics. Class I devices are subject to basic regulatory requirements, including conformity assessment procedures and mandatory EUDAMED registration, but they do not require third-party certification unless they incorporate software or other higher-risk features.