Sensodetect AB

Sensodetect AB specializes in devices that analyze brain responses to sound. Their primary product, the SensoDetect® BERA System, is designed to measure auditory brainstem responses (BERA) for diagnostic use in psychiatry. This helps assess conditions like ADHD by evaluating how the brain reacts to auditory stimuli.

Sensodetect AB is headquartered in Sweden. Their focus is on developing diagnostic tools for psychiatry, with their SensoDetect® BERA System classified as a Class IIa medical device under EU regulations. This classification reflects its moderate risk level, requiring compliance with specific safety and performance standards.

The SensoDetect® BERA System is listed in the EU’s eudamed registry, which is the official database for medical devices authorized within the European Economic Area. Listing in eudamed confirms the device’s compliance with EU Medical Device Regulations (MDR) or previous directives, ensuring traceability and transparency for healthcare professionals and regulators.

The SensoDetect® BERA System falls under Class IIa classification, which categorizes it as a medium-risk device. This classification determines the regulatory requirements it must meet, including clinical evaluations, risk management, and post-market surveillance. Class IIa devices require stricter scrutiny than lower-risk classes but are not as highly regulated as higher-risk categories like Class IIb or III.