It means the waste fluid disposal system can now be marketed in 32 European countries.
"Receipt of the CE mark is an important milestone for Skyline Medical and we are very excited to be able to expand the reach of our STREAMWAY System to Europe,” said Dr Carl Schwartz, chief executive
"We have already held preliminary discussions with a few European distributors, and with the CE mark in hand we can now advance those negotiations while beginning dialogues with others.
“We are optimistic that we can record our first product sale under the CE mark before year-end, and ramp up STREAMWAY’s availability throughout Europe by early 2018. Europe presents a rich market opportunity we are eager to pursue."
The system is an FDA-cleared waste fluid disposal system that virtually eliminates staff's exposure to blood and other potentially infectious fluids.
It can connect directly to a facility's plumbing system to automate the collection, measurement and disposal of waste fluids.
As of March 31 this year, Skyline Medical customers have installed 103 such systems in 52 facilities across 20 states, and in Canada.
Shares lifted 21.47% to $1.98.