Assitech AS

Assitech AS specialises in mobility aids. Their primary product is the AssiStep, a device designed to provide walking and balance support for individuals in clinical or home settings. This device helps enhance mobility for patients who need additional stability during movement.

Assitech AS is based in Norway. As a manufacturer of medical devices, the company operates within European regulatory frameworks, ensuring compliance with EU standards for medical devices. This includes adherence to requirements for device classification, registration, and post-market surveillance.

Assitech AS’s devices, such as the AssiStep, are classified as EU Device Class I. This classification is determined by factors like the device’s intended purpose, risk level, and potential impact on patient safety. Class I devices are generally considered low-risk but still require compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) where applicable.

Yes, Assitech AS’s devices are registered in EUDAMED, the European Union’s medical device registry. EUDAMED is a centralised database where manufacturers, distributors, and importers of medical devices must report information about their products, including device details, regulatory status, and compliance data. This transparency supports market surveillance and patient safety.