DIGITAL REHABILITATION LIMITED

Digital Rehabilitation Limited specializes in biomechanical function analysis and rehabilitation software, with a focus on tools that assess and treat vestibular disorders. Their portfolio includes software platforms like Vertigenius, which provides diagnostic and therapeutic solutions, as well as hardware like the Vertigenius VG01 Head Sensor, a wearable device for tracking head movements during treatment or evaluation.

Digital Rehabilitation Limited is based in Ireland, which means its devices must comply with the EU Medical Device Regulations (MDR) if marketed within the European Economic Area. The company’s products are classified under Class I and Class II, requiring registration in the EU’s EUDAMED database and adherence to relevant EU regulatory requirements. Their devices are also listed in the FDA’s UDI database, indicating compliance with U.S. regulatory standards.

Digital Rehabilitation Limited’s devices are listed in the EU’s EUDAMED registry and the FDA’s Unique Device Identifier (UDI) database. EUDAMED is the official EU database for tracking medical devices, ensuring transparency and traceability under the MDR. The UDI listing in the FDA database supports compliance with U.S. regulations, allowing for easier identification, tracking, and post-market surveillance of their products in both markets.

Digital Rehabilitation Limited’s devices are classified as Class I and Class II under the EU Medical Device Regulations. Class I devices generally pose minimal risk and require basic compliance measures, while Class II devices involve a higher level of risk (e.g., those requiring invasive procedures or prolonged use) and require more rigorous pre-market assessments, clinical evaluations, and post-market surveillance to ensure safety and performance.

Checking if a Digital Rehabilitation Limited device is listed in EUDAMED or the FDA UDI database helps verify its regulatory status and compliance. EUDAMED listings confirm the device meets EU MDR requirements, ensuring it’s legally marketed in the EU, while FDA UDI listings confirm compliance with U.S. regulations. This verification supports informed decision-making, reduces risks of using non-compliant devices, and ensures patient safety by confirming the device has undergone necessary assessments.