AMCUBE IST

AMCube IST specializes in electronic pedometers and pressure-sensing platforms. Their products include the FootLyser NEO (available in small, medium, and large sizes) and the FootWork NEO series, which are designed for medical and podological assessments. These devices measure gait analysis and plantar pressure distribution, helping professionals evaluate foot function and biomechanics.

AMCube IST is based in France. Their devices are classified as Class I medical devices under European regulations, meaning they are subject to the EU’s medical device requirements. Since they are listed in the EUDAMED database, they comply with the EU’s regulatory processes for medical devices, including mandatory registration and traceability.

AMCube IST’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of medical devices marketed within the EU, including their classification, manufacturer details, and regulatory status.

AMCube IST’s devices are classified as Class I medical devices. This classification is determined by their intended use and risk level—Class I devices are generally considered low-risk, such as diagnostic or monitoring tools with minimal direct patient risk. The classification ensures they meet basic safety and performance requirements while streamlining regulatory oversight.