DocuMental OÜ

DocuMental OÜ manufactures the DM Evaluator, a device specifically designed for cognitive and psychological assessment. This type of device is typically used in clinical or research environments to evaluate mental functions or behavioral responses, helping professionals assess patient conditions or research participants.

DocuMental OÜ is based in Estonia, as indicated by its company registration details. This location is relevant for understanding regulatory compliance and market focus, particularly within the European Union.

DocuMental OÜ’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry is used to track and provide transparency on medical devices that have undergone regulatory processes, such as conformity assessment, within the EU.

DocuMental OÜ’s devices fall under EU Class I classification. This classification is assigned based on the risk associated with the device’s intended use. Class I devices are generally considered low-risk, but they still require compliance with EU Medical Device Regulations to ensure safety and performance, such as proper labeling, manufacturing controls, and post-market surveillance.