Point of Care Urease Test for Endoscopy
Hepy Urease Test® is a Point of Care medical device intended for the rapid detection of Helicobacter pylori infection during endoscopic procedures. The product is used directly during the examination and is intended for professional use only.
Detection of Helicobacter pylori during endoscopic procedures
The test is intended for the detection of H. pylori in biopsy specimens obtained from the stomach or duodenum. The result is available during the examination, enabling immediate assessment of infection presence without the need for laboratory processing.
Point of Care
Result available during the procedure.
Visual Readout
Color-based reaction observed directly on the test.
Dry Test
Ready to use without preparation.
No Laboratory Required
No external laboratory analysis necessary.
Rapid diagnostics directly during endoscopic procedures
Hepy Urease Test® has been designed as a medical device integrating the requirements of endoscopic diagnostics, logistical stability and compliance with international quality systems.
The product is not solely a diagnostic tool but part of a broader clinical and distribution framework. It is intended for use directly during endoscopic procedures while taking into account practical conditions of storage, transport and long-term inventory planning.
Production is carried out in the European Union under a certified Quality Management System compliant with EN ISO 13485:2016, covering processes for design and development, production and sale. This structured approach supports process consistency, parameter stability and regulatory compliance across international markets, enabling safe clinical use and efficient B2B distribution.
