RE:EU-CE Approval???? The site is for
devices commercially available with CE-IVD mark THRM says they have the CE-ONLY approval
Therma Bright Inc. has received CE approval certification but meets:
The EU declaration of conformity indicates that the AcuVid COVID-19 rapid antigen saliva test complies with all the requirements of European IVDD (in-vitro diagnostic device) legislation. Slight differences just one letter can make a difference.
Does ACUVID have the CE Mark or the CE-IVD there is no CD-IVDD
Can also look at FINDDX.ORG
https://www.finddx.org/test-directory/?_assay_target=antigen&_regulatory_status=ce-ivd TheScientist01 wrote: not trying to bash here coz I'm still holding 100k and hoping for this to break out. I understand that this isnt listed on HC website because they havent started testing in Canada.. Therma said they received EU-CE approval and CE only conditional sale... Soooooo why isnt this listed on the EU-CE approved covid diagnosis devices?? Anyone have any ideas? The website would have been updated by now coz its been over a month now. check it out and let me know.. im curious what you think. https://covid-19-diagnostics.jrc.ec.europa.eu/