No, there is CE marking for medical devices in the EU which means it has achieved conformity for the Medical Devices directive. Generally equivalent to FDA regulation.
Just beware there is an EU CE and Chinese export C E. They are different. I probably can't post a link but the search you need is this: CE eu markings CE china export.
CE is a mark of quality assurance and compliance. C E is not the same.
[edit for spelling]
Link for those curious https://en.m.wikipedia.org/wiki/CE_marking#China_Export
Though I believe neuromod is advertising CE compliance not ‘China Export’
If the space is meant to represent the gap between the C and E, then you have this backwards: the European mark has one letter-width space between the C and E, and the forged mark from China has the C and E right next to each other.
Re:Tinnitus Treatment from Neuromod
by ineedasername on Friday October 16, 2020 @07:02PM
(#24805839)
Thanks, I wasn't aware there was a more targeted review for medical devices, and updated my comment with a note to that effect.
However it does not seem comparable to a fairly rigorous FDA double-blind experimental process requirements, it only requires the manufacturer to provide a clinical evaluation that appears to be just a little more than a literature review [0][1]
[0]https://www.emergobyul.com/services/europe/ce-certification
[1]https://www.emergobyul.com/sites/default/files/eu-meddev-2_7...
There may be something here, but their presentation leaves a "snake oil" impression. Mostly because of their repeated emphasis on "CE" certification, as though that had any bearing on the effectiveness of this treatment. They even say it has "CE-mark certification for the treatment of tinnitus", which is really misleading, as CE simply means it complies with certain regulations regarding the construction of electronic devices, nothing at all about fitness for a given medical purpose.