The approval will allow the company to sell products in the European and other OUS markets.
The HypothermX Intravenous Fluid and Blood Warming Devices are used by healthcare professionals in clinical and field environments for warming blood, blood products and intravenous fluids prior to administration.
EMIT chairman and CEO Jeffery Sheldon said the documented improvement in clinical outcomes with first responder administration of blood, plasma, and blood products at the point of injury is enabled with firm’s product.
"The product’s ease of use and ability to warm sufficient resuscitative fluid volume over unmatched timeframes makes it ideal for military, air medical transport, mobile, remote, austere, and power challenged environments," Sheldon added.
The company noted that it also received ISO 13485:2003 and EN ISO 13485:2012 quality certification from SGS UK, a quality management system registrar.
EMIT develops and manufactures devices to treat hypothermia caused by traumatic, environmental, and procedural related occurrences.
