Poly Diagnostics is a European manufacturer of in vitro diagnostic medical devices, certified to ISO 13485 and CE‑marked under the IVDR (EU Regulation 2017/746).
Our mission is to enable better patient diagnosis by providing innovative, reliable, and accessible molecular tools that combine advanced technology with simplicity of use.
We design and manufacture real‑time PCR solutions for professional clinical laboratories, delivering accurate and dependable results across a wide range of diagnostic areas. All research, development, and manufacturing activities are performed in Luxembourg (European Union), ensuring high quality standards, regulatory compliance, and consistent product performance.
Poly Diagnostics quality is ensured through certifications issued by TÜV SÜD, a globally recognized provider of testing, certification, and auditing services for medical devices.
