Category and country
Diagnostics companies in Poland
7 diagnostics profiles in Poland. Every profile is hand-reviewed with leadership, certifications, and public sources.
Where does diagnostics cluster in Poland?
Wroclaw (3), Krakow (2), Lublin (1), and Warsaw (1) Most visible profiles: Bioavlee S.A., Diagnostyka S.A., Genomtec S.A., and Hemolens Diagnostics Sp. z o.o..
Which standards are already visible?
ISO-13485 (2) Latest review: 24 April 2026. Review cycle: April 2026.
Full list
Diagnostics profiles in Poland
7 profiles match the active filter.
Current review cycle
Bioavlee S.A.
WroclawPolandDiagnostics
Wroclaw diagnostic robotics company developing AI-powered rapid bacterial identification through image-analysis microbiology for point-of-care infectious-disease diagnosis.
- Lead
- Michal K. WroneckiChief Executive Officer
- Scale
- Medical-device and AI diagnostics delivery
Current review cycle
Diagnostyka S.A.
KrakowPolandDiagnostics
Poland's largest medical diagnostic laboratory network with 156 laboratories, over 1,100 patient collection points, and Warsaw Stock Exchange listing under the ticker DIA.
- Lead
- Jakub SwadzbaChief Executive Officer and Co-Founder
- Scale
- National clinical-diagnostic service delivery
Current review cycle
Genomtec S.A.
WroclawPolandDiagnostics
Wroclaw point-of-care molecular diagnostics developer with isothermal nucleic acid amplification technology (SNAAT) for cartridge-based respiratory and infectious-disease panels, listed on Warsaw Stock Exchange.
- Lead
- Miron TokarskiChief Executive Officer and Co-Founder
- Scale
- POC diagnostic device development
Current review cycle
Hemolens Diagnostics Sp. z o.o.
WroclawPolandDiagnostics
Wroclaw medical-device software company building Cardiolens FFR-CT Pro for non-invasive cardiology diagnostics through coronary CT and blood-pressure fusion with blood-flow simulation.
- Lead
- Wojciech JezewskiChief Executive Officer
- Scale
- Medical-device software delivery
Current review cycle
intoDNA S.A.
KrakowPolandDiagnostics
Krakow molecular diagnostics biotech with the proprietary STRIDE DNA-break detection platform, supplying biomarker services for PARP inhibitors, DDR programs, and companion-diagnostic development.
- Lead
- Magda KordonChief Executive Officer and Co-Founder
- Scale
- Biomarker services operation
Current review cycle
BioMaxima
LublinPolandDiagnostics
Lublin diagnostics and microbiology company producing culture media, rapid tests, and IVD products from a substantial Polish operating base.
- Lead
- Lukasz UrbanChief Executive Officer
- Scale
- Diagnostics platform
Current review cycle
Scope Fluidics
WarsawPolandDiagnostics
Warsaw diagnostics and microfluidics company developing rapid antimicrobial-resistance and molecular-diagnostics platforms from a Polish innovation base.
- Lead
- Piotr GarsteckiPresident of the Management Board
- Scale
- Diagnostics platform
FAQ
Frequently asked questions on this category
- What is a diagnostics company?
- Companies developing or manufacturing tests, assays, instruments, reagents, or platforms used to identify disease or biological state. The category includes IVD manufacturers (regulated medical devices), clinical lab networks (running tests), and assay developers (creating new tests). All EU diagnostic products fall under IVDR (in vitro diagnostic regulation, fully applicable since 2022).
- Which European countries lead in diagnostics?
- Switzerland (Roche Diagnostics is the world's largest IVD company). Germany (Qiagen, Siemens Healthineers, altona Diagnostics, CeGaT, Hummingbird Diagnostics, BioSpring). The Nordics with diagnostic platforms. The Baltics have growing molecular diagnostics (Asper Biogene in Estonia, E. Gulbis Laboratory in Latvia, several Lithuanian platforms). Poland adds Diagnostyka S.A., the country's largest clinical lab network.
- What certifications should a diagnostics company hold?
- For IVD products: ISO 13485 (quality management) + CE marking under IVDR. For clinical lab services: country-specific accreditation (e.g. ISO 15189). For molecular tests with regulatory submissions: GLP for any nonclinical safety component. FDA-inspected sites are common among manufacturers selling into the US.
- How are diagnostic companies verified in this directory?
- Every profile is hand-reviewed: leadership confirmed by primary source, physical site address sourced from official disclosures, ISO 13485 / CE / IVDR claims backed by certification documents, and a registry note explaining current operating context.
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