Zyno Medical has received European CE Mark approval for its Z-800 Infusion system including models Z-800, Z-800F, Z-800W and Z-800WF, and Zyno administration sets.
The CE Mark will allow Z-800 Large Volume Infusion Pump system to be sold in the European Union (EU) and other countries that recognise or need the approval.
With the Z-800 Large Volume Pump system, the company focused on the US alternate care market.
The Z-800 system has six infusion therapy modes, a protocol mode to save frequent therapies and an optional IV set based anti-free flow feature.
In order to create an integrated infusion system, the Z-800W pump series adds wireless communication capabilities and a cloud-based software interface application.
The system provides seamless integration of pharmacy dispense and electronic medical record (EMR) systems for auto-programming and auto-documentation.
Zyno Medical president Dr Chaoyoung Lee said: "The Z-800 systems unique features and ease-of-use will provide infusion centers with confidence, improved patient safety, and increased workflow efficiency.
"The approval of the CE Mark for the Z-800 system is the next step in the growth of Zyno Medical.
"The system has proven itself in the US market and we are pleased to have the opportunity to provide the European market with a reliable and cost effective infusion solution."
The company said the Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction or supervision of a physician or another certified health care professional.
In order to meet the unique and challenging needs of oncology infusion centers, specialty pharmacy, and alternate site providers, the Z-800 system was developed with input from users.
Image: Z-800 Infusion Pump system. Photo: courtesy of PRNewsFoto / Zyno Medical, LLC.