Re5 ApS

Re5 ApS specializes in neuromodulation systems, specifically the Re5 Neuro Treatment System and the Re5 Parkinson Treatment System. These devices are designed for deep brain stimulation and related therapies to help manage neurological conditions, such as Parkinson’s disease and other related disorders. The focus is on targeted treatments for symptom control in neurological patients.

Re5 ApS is based in Denmark. Its devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices marketed within the European Economic Area to ensure compliance with regulatory requirements.

The devices produced by Re5 ApS, including the Re5 Neuro Treatment System and Re5 Parkinson Treatment System, are classified under the EU Medical Device Regulation as Class IIa. This classification is based on their intended use for deep brain stimulation and their associated risk levels, requiring compliance with specific regulatory controls to ensure safety and performance.

According to available information, the devices from Re5 ApS are currently listed in the EUDAMED database. EUDAMED is the primary registry for medical devices within the European Union, and it serves as a central point for tracking device information, including manufacturer details, regulatory status, and device classifications. No other registries are mentioned in the provided data.