CE marked as a medical device in the EU, according to MDD 93/42/EEC, class IIa. Manufactured by MAG&More GmbH, München, Germany, ISO 13485 certified. Distributed by ANT Neuro and eemagine, part of the neuromotion group. Outside the EU, the system is intended for research and educational use only. In the United States, limited by federal law to investigational use only.