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Re:Tinnitus Treatment from Neuromod by becurious on Friday October 16, 2020 @06:31PM (#24805652)
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.
Re:Tinnitus Treatment from Neuromod by Unibod on Friday October 16, 2020 @06:47PM (#24805749)
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]
Re:Tinnitus Treatment from Neuromod by lgats on Saturday October 17, 2020 @02:05AM (#24807771)
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’

Re:Tinnitus Treatment from Neuromod by wlonkly on Friday October 16, 2020 @11:32PM (#24807264)
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...