SENSE4CARE, S.L.

Sense4Care, S.L. specializes in wearable medical devices focused on monitoring and analyzing movement patterns in individuals. Their primary product, the STAT-ON system, is designed to track and assess how people move, aiming to enhance quality of life for users. These devices are tailored for applications where movement analysis is critical, such as rehabilitation or activity monitoring.

Sense4Care, S.L. is based in Spain (ES), which means its devices must comply with EU medical device regulations. Since their products fall under EU Class IIa classification, they are subject to stricter regulatory oversight compared to lower-risk devices. The company registers its devices in the EUDAMED database, which is the official EU portal for tracking medical device information, ensuring transparency and traceability across the European market.

Yes, Sense4Care’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing is important because it demonstrates compliance with EU regulations, provides transparency for healthcare professionals and regulators, and ensures that the devices meet the necessary safety, performance, and quality standards before they enter the market. It also allows authorities to track devices throughout their lifecycle.

Sense4Care’s devices are classified as EU Class IIa medical devices. This classification indicates a moderate risk level, requiring compliance with stricter regulatory controls compared to Class I devices. Class IIa devices must undergo additional scrutiny, including clinical evaluations and risk management processes, to ensure their safety and effectiveness before authorization. The classification helps regulators, healthcare providers, and users understand the device’s risk profile and necessary precautions.