Company Performance Metrics
HEPY is a medical device manufacturer specializing in urease tests for the detection of Helicobacter pylori infection during endoscopic procedures. The company designs, develops and produces point of care in vitro diagnostic devices that use gastric or duodenal biopsy specimens to provide rapid visual results without laboratory processing. Its core
product, Hepy Urease Test, is a dry diagnostic test plate intended for professional medical use in endoscopy units. HEPY operates under a certified quality management system compliant with EN ISO 13485:2016, covering design, manufacturing, quality control and post‑market surveillance. The company distributes its medical devices through a structured B2B model, working with regional distributors and medical device partners across multiple international markets. It also offers private label and OEM contract manufacturing services for organizations seeking branded urease tests within an EU regulatory framework.
