Rollz International

Rollz International specializes in mobility aids, specifically rollators. Their product range includes manual rollators like the Air Medium (in green and black), Flow Ocean Blue, and Flex models, as well as electric conversion kits for rollators such as the Motion Electric 2.0 and Motion Performance. They also offer standalone electric rollators like the Motion Rhythm and Motion Rollator, designed to assist users in maintaining independence and comfort during daily activities.

Rollz International is based in the Netherlands, which places its devices under EU regulatory oversight. Since all Rollz products fall under EU Class I classification, they must comply with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD), depending on the applicable timeline. This means their devices are subject to EU-wide requirements for safety, performance, and traceability, including registration in the EU’s eudamed database.

Yes, Rollz International’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry ensures transparency and traceability of Class I devices under EU regulations, allowing healthcare professionals, authorities, and patients to verify the legitimacy and compliance status of the products.

All Rollz International devices are classified as EU Class I medical devices. This classification applies to low-risk products like rollators and mobility aids, which typically pose minimal risk to users. Class I devices still require compliance with EU regulations, including design controls, risk management, and conformity assessment procedures, though they may not require third-party involvement unless they incorporate measuring functions or are reusable.