MOBILE-TECHNICS BV

Mobile-Technics BV specializes in manufacturing tricycles, including models like the TRI BIKE, TRI BIKE ECO TRIKE, and TRI BIKE CLASSIC S. These devices are designed to assist individuals with mobility limitations, providing stability and ease of use for both adults and children. The company’s focus is on creating accessible mobility solutions tailored to diverse needs.

Mobile-Technics BV is based in Belgium, which places its operations under EU regulatory oversight. Since its devices are classified as EU Class I medical devices, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. The company’s location ensures alignment with EU standards for device safety, performance, and traceability.

Mobile-Technics BV’s devices are registered in the eudamed database, the official EU portal for medical device information. This registry ensures transparency and allows healthcare professionals, authorities, and patients to access details about the company’s Class I tricycles, including their regulatory status and compliance with EU requirements.

Mobile-Technics BV’s tricycles are classified as EU Class I medical devices. This classification is determined by their intended use—assisting individuals with mobility limitations—and their risk profile, which is deemed low under EU regulations. Class I devices typically undergo essential requirements checks but may not always require mandatory conformity assessment procedures, though traceability and labeling remain mandatory.