FIZE Medical Receives CE Mark and UKCA Certification for Its FIZE kUO® System, Launching Commercial Operations Across Europe and the UK
With regulatory clearance in place, FIZE Medical expands its global commercial footprint across Europe and the UK alongside existing operations in North America and Japan
JERICHO, N.Y., July 27, 2026 /PRNewswire/ -- FIZE Medical, a company advancing precision fluid management in critical care, today announced it has received CE mark and UKCA certification for its FIZE kUO® System. This regulatory milestone clears the way for the company to immediately initiate full commercial activities and product distribution across Europe the UK.
The CE Mark and UKCA certification represents another significant milestone in FIZE Medical's global growth strategy. Together with its established commercial presence in North America and Japan, the company is now positioned to expand its reach across the world's major healthcare markets.
"Receiving the CE Mark and UKCA Certification is a pivotal milestone for FIZE Medical," said Dror Zerem, CEO of FIZE Medical. "It validates the safety, performance, and clinical value of our technology and marks an important step in bringing our solution to hospitals in the EU and the UK. We look forward to partnering with hospitals across Europe and the UK to equip intensive care teams with continuous, real-time digital monitoring that supports precision fluid management, earlier clinical intervention, and better patient outcomes."
To support its commercial expansion in Europe and the UK, FIZE Medical has established strategic partnerships with leading medical device distributors across key European markets. In parallel, the company has localized its platform for the initial launch countries, providing native-language interfaces that facilitate seamless adoption by healthcare professionals. With its commercial infrastructure now in place, FIZE Medical is ready to begin serving hospitals across Europe and the UK.
For more information about FIZE Medical and its global commercial availability, please visit https://fizemedical.com.
About FIZE Medical
FIZE Medical is a medical technology company dedicated to advancing fluid management in critically ill patients. Its proprietary FIZE kUO system provides real-time, automated monitoring to support precision fluid management, early intervention, and improved patient outcomes. FIZE Medical is committed to redefining fluid management through continuous innovation, AI-driven data insights, and clinical evidence.
Media Contact:
Eran Blankenstein
eranblank@fizemedical.com
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