I am a bit confused now, complicated as it all is.
You said that class II products only need cadastre. How about class I? The products are tampons (for nose and ear), one is qualified as class I, the other as class II (don't know why, same principle).
According to the distributor and cadastre holder both products have cadastre, no need for registration (I just want to be sure, since you said cadastre for class II).
So my question is, can products class I also qualify for cadastre? And cadastre means also that no B-GMP-audit/certification is needed?