Respiri investor Presentation, page-2

I was trying to look for the clinical trial result that RSH used to get CE and TGA approval for the Wheezo device and I found it in the 2019 AGM presentation which indicated that the device had a sensitivity of 92% and specificity of 80% but this was tested the stethoscope (which we know isn't that accurate) and this clinical trial was only blind and not double blind with a small sample size, there is supposedly a further clinical trial against spirometry that hasn't been completed, was the CE and TGA approval only for device?