Hepy Urease Test na stalowym stole produkcyjnym w zakładzie produkującym testy medyczne do wykrywania Helicobacter pylori
Diagnostyka Helicobacter pylori podczas badania endoskopowego
Test ureazowy Point of Care do wykrywania Helicobacter pylori
Produkcja wyrobów medycznych w certyfikowanym systemie jakości

H. pylori Urease Tests

Design and manufacturing of certified Point of Care medical devices for the detection of Helicobacter pylori during endoscopic procedures.

  • B2B Contact: office@hepytest.com
Design and manufacturing process of diagnostic tests in compliance with European quality standards
Medical Manufacturing

Design and production of diagnostic tests in compliance with European regulatory requirements and recognized quality standards.

ISO 13485 certified Quality Management System in medical device manufacturing
Quality System

Certified Quality Management System compliant with EN ISO 13485:2016 covering the full medical device lifecycle.

International medical device distribution and B2B cooperation with partners
Global Distribution

Cooperation with partners and distributors across international markets under a structured B2B model.

15+

Distribution Countries

International Market Presence

Our Specialization

Point of Care Urease Tests

Rapid Diagnostics

Result available during the procedure

  • From 1 minute
  • Endoscopy
  • No laboratory required
Dry Test

Ready to use

  • No liquids
  • No gels
  • No water
Visual Readout

Clear color reaction of the test

  • Color change
  • In-clinic use
  • Immediate
Product Stability

Efficient logistics

  • Wide temperature range
  • Standard transport
  • No cold chain required
Long Shelf Life

Four-year product stability.

  • 4 years
  • Storage flexibility
  • Inventory planning
EU Manufacturing

Regulatory-compliant production.

  • European Union
  • EN ISO 13485
  • Medical devices
Standards

EN ISO 13485:2016.

Quality and Compliance

Certified Quality Management System for Medical Devices

Design and development, production and sale processes at HEPY are carried out under a certified Quality Management System compliant with EN ISO 13485:2016.

  • Design and manufacturing in accordance with European Union regulations
  • Quality oversight throughout the entire product lifecycle

Our Solutions

HEPY Medical Devices

Point of Care medical device for the detection of
Helicobacter pylori infection.

Diagnostyka Helicobacter pylori podczas badania endoskopowego

Clinical Application

The test is intended for the detection of Helicobacter pylori in biopsy specimens obtained from the stomach or duodenum during endoscopic procedures. Intended for professional use only.

Procedura diagnostyczna Point of Care w warunkach klinicznych

Procedure

A standardized procedure enabling result acquisition directly during the examination, without the need for additional diagnostic equipment.

For Partners

Distribution Partnership

We are actively seeking new distribution partners interested in introducing certified HEPY medical devices to local markets. We offer a stable product, EU-based manufacturing and regulatory support aligned with international standards.

B2B Cooperation
Operational Scale

International Distribution

HEPY products are distributed across international markets under a structured B2B model based on long-term cooperation, regulatory compliance and consistent quality standards.

Global Reach

For Distributors and Partners

Product and Company Updates

HEPY Ltd.

European medical device manufacturer specializing in certified Point of Care urease tests for the detection of Helicobacter pylori.