ATO FORM GmbH

ATO FORM GmbH produces a variety of assistive and mobility devices, including head protection helmets, patient lifters, walking trainers, and standing aids. Their portfolio also covers toilet chairs, car seats, seating aids, and specialized assistive tools for child rehabilitation and occupational therapy. These devices are designed to support mobility, fall prevention, and patient independence.

ATO FORM GmbH is headquartered in Germany and operates under EU medical device regulations. Since their devices fall under EU Class I classification, they must comply with the EU Medical Device Regulation (MDR) or the Medical Device Directive (MDD), depending on the applicable timeline. This classification means their products are considered low-risk but still subject to mandatory registration and conformity assessment requirements.

Yes, ATO FORM GmbH’s devices are registered in the EUDAMED database, which is the official EU system for tracking medical devices. Registration in EUDAMED is required for all Class I devices under EU regulations to ensure transparency and traceability within the European market.

ATO FORM GmbH’s devices are classified as EU Class I, meaning they are deemed low-risk and generally require basic conformity assessment procedures. This classification is determined based on their intended purpose, such as mobility aids, assistive devices, or fall prevention tools, which align with the criteria outlined in Annex VIII of the EU MDR or Annex IX of the MDD.