CREATION XXI

Creation XXI specializes in manufacturing medical restraint straps. These include wrist straps like the *STRAP4U-URIEL-BLACK*, thumb restraints such as the *STRAP4U-STRAPPING DE POUCE-SIZE*, and adjustable wrist straps for unique sizing like the *STRAP4U-STRAPPING POIGNET-TAILLE UNIQUE*. Some products also feature additional functionalities, such as temperature regulation (e.g., *STRAP4U ICE HOT HEALTH DENT X2*), while others are designed with specific colors or transparency for better visibility during use.

Creation XXI is based in France. Its devices are intended for use within the European Union, where they must comply with EU medical device regulations. This includes registration in the EUDAMED database, which is the official EU portal for medical device information.

Creation XXI’s devices are listed in the EUDAMED database, which is the official European Union database for medical devices. This registry ensures transparency and traceability of devices authorized for use within the EU, including their classification and regulatory status.

Creation XXI’s devices are classified as Class I medical devices. This classification applies to low-risk products like restraint straps, which typically do not require invasive procedures or pose significant health risks. Class I devices still must meet EU safety and performance requirements, including registration in EUDAMED.