Compumedics - alpha trace GmbH

Compumedics - alpha trace GmbH specializes in neurophysiological monitoring devices. Specifically, they produce portable and clinical-grade systems like the NeuroSpeed-EEG for recording electroencephalograms (EEG) and the NeuroSpeed-PSG for conducting polysomnography (PSG) studies. These devices are used for assessing sleep disorders and neurological conditions in both hospital and home environments.

The company is headquartered in Austria, which is its primary location for manufacturing and operations.

The devices produced by Compumedics - alpha trace GmbH are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry helps healthcare professionals and regulators verify the legitimacy and classification of devices.

The devices manufactured by Compumedics - alpha trace GmbH fall under Class IIa classification according to EU medical device regulations. This classification is assigned based on the risk associated with the device, with Class IIa indicating a moderate risk level that requires additional scrutiny and compliance measures.