Decision Diagnostics Corp (DECN)

[IPwatcher]

This seems to be SUGGESTING that a Declaration of Conformity is all that is required to CE mark a diagnostics device!?
Good luck with that! NOT A CHANCE IN HELL!
Let me get this... They are claiming to use these things to diagnose an infectious disease!? And then claiming that the EU MDR (Medical device Regulatory) requirements DON'T Apply to it?

If it isn't a diagnostic device, What is it for???? No way will that wash!
The things will be impounded at the dock!

No way is thing thing getting a VALID IVD CE mark! NONE WHATSOEVER!