Category and country
Diagnostics companies in Germany
5 diagnostics profiles in Germany. Every profile is hand-reviewed with leadership, certifications, and public sources.
Where does diagnostics cluster in Germany?
Mainz (2), Hamburg (1), Heidelberg (1), and Hilden (1) Most visible profiles: altona Diagnostics GmbH, ORGENTEC Diagnostika, Mainz Biomed, and Hummingbird Diagnostics.
Which standards are already visible?
ISO-13485 (3) and FDA-Inspected (1) Latest review: 24 April 2026. Review cycle: April 2026.
Full list
Diagnostics profiles in Germany
5 profiles match the active filter.
Current review cycle
altona Diagnostics GmbH
HamburgGermanyDiagnostics
Hamburg ISO 13485-certified molecular diagnostics manufacturer building CE-IVD real-time PCR assays for infectious disease, with global distribution through subsidiaries and a historical FDA EUA track record for its RealStar Ebolavirus assay.
- Lead
- Soenke FriedrichsenManaging Director (joint with Hans Kuhn)
- Scale
- Commercial CE-IVD diagnostic manufacturing
Current review cycle
ORGENTEC Diagnostika
MainzGermanyDiagnostics
Mainz diagnostics company focused on autoimmune and infectious-disease testing, with broad immunology assay operations from a German IVD platform.
- Lead
- Gregoire AllazChief Executive Officer
- Scale
- Diagnostics platform
Current review cycle
Mainz Biomed
MainzGermanyDiagnostics
Mainz diagnostics company developing molecular screening tests for colorectal and pancreatic cancer from a German diagnostics base.
- Lead
- Guido BaechlerChief Executive Officer
- Scale
- Diagnostics platform
Current review cycle
Hummingbird Diagnostics
HeidelbergGermanyDiagnostics
Heidelberg molecular diagnostics company developing miRNA-based liquid-biopsy assays for neurological disease and oncology applications.
- Lead
- Tillman WeissChief Executive Officer
- Scale
- Diagnostics platform
Current review cycle
QIAGEN
HildenGermanyDiagnostics
German diagnostics and sample-to-insight infrastructure titan centered on molecular testing, sample prep, and bioinformatics workflows in Hilden.
- Lead
- Thierry BernardChief Executive Officer and Managing Director
- Scale
- Global diagnostics manufacturing
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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