We are happy to announce that we have received CE certification for our XCSITE 100 #tDCS/#tACS device. As you may know, there are different levels and types of CE certifications. Our main goal was to be able to sell to Europe, where CE certification of electrical equipment is required. We had many requests from Europe and now we are finally able to offer our XCSITE 100 to our European customers. We have received CE certification by declaring conformity against Low Voltage Directive (LVD) 2014/35 EU with Standard 601010-1 2010. This certification provides assurance about electric safety of the device. It is important to note that this does not imply certification as a medical device.
Our CE certification gives you the assurance that an independent test laboratory has reviewed and tested the device against an accepted standard of electric safety. In our experience having such third-party certification can simplify the conversation with IRBs who are unfamiliar with the technology.
Please do not forget that #tDCS and #tACS are investigational use only and that XCSITE 100 is not a medical device. We are happy to answer any questions you may have about this or anything else.