It appears Karmelsonix have FDA approvals and CE approval...

It appears Karmelsonix have FDA approvals and CE approval according to this link.

http://www.karmelsonix.com/analysts.html

Also I recall
Apparently insurance codes were assigned in the USA. A company announcement that is in the KSX page on Hot Copper hAS A list of PDFs. One of the PDF included an announcement related to the insurance codes and reimbursement to the doctors. I don't recall which product.

Each country or market may have different requirements.

KSX appear to breaking into several markets.

The partnering for distributions with the major medical device companies like OMRON with established sales and marketing in many of the major countries/markets as an accelerator. OMRON is a big deal.
The downward direction of the stock price soon after that announcement has me puzzled and made investors very cautious.

Everyone I think expects adding a US listing for the stock will significantly increase trade volume and help the stock price because of the larger number of available investors.

Good luck with timing this. Advice is welcome.