Profile of the Company

European medical device manufacturer for Helicobacter pylori diagnostics

Design and manufacturing of diagnostic tests for professional endoscopic use

We design and manufacture diagnostic tests intended for professional medical use during endoscopic procedures

HEPY Ltd. is a medical device manufacturer specializing in urease tests for the detection of Helicobacter pylori infection. The company’s activities include design and development, production and distribution of medical devices in compliance with European Union regulatory requirements and international quality standards.

5+

Years of Experience

15+

Distribution Countries

Our Operations

Medical Manufacturing

Medical device manufacturing carried out under defined processes, quality oversight and compliance with EN ISO 13485:2016 requirements.

Regulatory Compliance

Design and manufacturing of products in accordance with applicable European Union regulations governing medical devices.

B2B Model

Cooperation with distribution partners under a structured B2B model based on long-term relationships and stable terms of collaboration.

Management Structure

Executive Board and Key Operational Roles

The Management Board of HEPY Sp. z o.o. is responsible for the company’s strategic direction, operational oversight and business partner relations.

Magdalena Gołębiewska
Magdalena Gołębiewska

Director of Manufacturing & Operations

Sonia Majewska
Sonia Majewska

Customer Operations & Marketing Coordinator

Filip Piórkowski

Head of International Sales

Operational Scale and Reliability

Facts Demonstrating Stability and Growth

Order Continuity
98%

High level of repeat orders within the B2B distribution model, confirming stable and long-term cooperation with partners.

Units Supplied
1M+

Total number of urease tests placed on the market since the company’s establishment, reflecting operational scale and continued growth potential.

Quality System
EN ISO 13485

Certified Quality Management System covering processes for design and development, production and sale of medical devices.