Well, if I'm reading this CE mark timeline correctly, I think it was Pennylane, or High, that said (4 to 6 week's) after the 16th, b-4 approval, So it's in the hopper, and these are hard, hand held devices, there not plastic heart implants, or battery operated pumps of some sort, We could get the stamp, sooner then you think, Bob's pushed it back to December, I think he's just covering his basses, and he's buttering up Emergo and Expert, they would look bad if this doesn't clear, 
The world is watching, Solos is not your average ACME medical supply, down on first avenue.