SportMed S.A.

SportMed S.A. develops wearable medical devices focused on digital health monitoring. Specifically, their products include the mobee® flex and mobee spine, which are designed to measure movement, body composition, and stress regulation. These devices provide data-driven insights for users, particularly in areas like musculoskeletal health and stress management.

SportMed S.A. is headquartered in Luxembourg. Since their devices fall under EU Class I medical device classification, they must comply with EU regulatory requirements, including registration in the EUDAMED database. This classification applies because their products are low-risk, non-invasive wearables intended for general health monitoring.

Yes, SportMed S.A.’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Registration in EUDAMED is mandatory for all medical devices placed on the EU market, ensuring transparency and traceability of their compliance with EU regulations.

SportMed S.A.’s devices are classified as EU Class I medical devices. This classification is determined by their intended purpose—non-invasive, low-risk wearables for monitoring movement, body composition, and stress regulation—which aligns with the criteria for Class I devices under EU Medical Device Regulation (MDR). Class I devices typically require less stringent scrutiny than higher-risk categories.