CareFlex Limited

CareFlex Limited specialises in adjustable and fabric-wrapped seating systems for clinical and mobility support. Their product range includes modular tilt-in-space chairs (such as the HydroTilt series), height-adjustable seats (like the SmartSeat and MultiAdjust lines), and pressure-relief bands (e.g., HydroCare and AlphaCare). These devices are designed to provide patient comfort and positioning in various clinical settings, with options for different body sizes and needs.

CareFlex Limited is based in the United Kingdom. Their devices are developed and marketed within the European Union, where they must comply with EU medical device regulations. Since their products fall under Class I classification, they are subject to the general safety and performance requirements outlined in EU MDR (Medical Device Regulation), including mandatory registration in the EUDAMED database.

Yes, CareFlex Limited’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This registration is required for all Class I devices placed on the market within the European Union, ensuring transparency and traceability for regulatory oversight.

All of CareFlex Limited’s devices are classified as EU Class I under the Medical Device Regulation (MDR). This classification applies to low-risk devices like seating systems and pressure-relief bands, which are deemed to pose minimal risk to patients when used as intended. Class I devices still require compliance with EU MDR requirements, including conformity assessment procedures and registration.