Verification evidence is still being completed.
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altona Diagnostics GmbH
Hamburg, Germany
- Verified lead
- Soenke Friedrichsen
- Lead status
- STATUS: VERIFIED APRIL 2026
- Leadership verification
- Managing Director (joint with Hans Kuhn)
- 2026 technical specialization
- Molecular Diagnostics, Real-Time PCR Assays, and Global Infectious Disease Testing
- Review cycle
- 24 April 2026
- Full address
- Moerkenstrasse 12, 22767 Hamburg, Germany
- Site coordinates
- Verification evidence is still being completed.
- Editorial review
- Memel Biotech editorial review
- Official leadership source
- altona Diagnostics press release confirming Soenke Friedrichsen and Hans Kuhn as joint Managing Directors from 1 July 2024.
- Editorial note
- Hamburg molecular diagnostics manufacturer with named joint management, ISO 13485 certification, a broad CE-IVD assay portfolio, and a global subsidiary footprint across Americas and APAC.
Molecular Diagnostics, Real-Time PCR Assays, and Global Infectious Disease Testing
ISO 13485 certification, CE-IVD assay approvals, Historical FDA EUA
Hamburg molecular diagnostics manufacturer with named joint management, ISO 13485 certification, a broad CE-IVD assay portfolio, and a global subsidiary footprint across Americas and APAC.
Review coverage
Leadership
Facility
Certifications
Capabilities
Partners
Sources
Quality
Editorial verificationMemel Biotech directory review sign-off
Report generated02 Jun 2026, 01:40
Company profile · Hamburg, Germany
altona Diagnostics GmbH
Molecular Diagnostics, Real-Time PCR Assays, and Global Infectious Disease Testing · Commercial CE-IVD diagnostic manufacturing
Hamburg molecular diagnostics manufacturer with named joint management, ISO 13485 certification, a broad CE-IVD assay portfolio, and a global subsidiary footprint across Americas and APAC.
- Lead
- Soenke Friedrichsen (verified ↗)
- Address
- Moerkenstrasse 12, 22767 Hamburg, Germany (source ↗)
- Compliance
- ISO 13485 certification · CE-IVD assay approvals · Historical FDA EUA
- Last reviewed
- 24 Apr 2026 (1mo ago)
- Scale
- Commercial CE-IVD diagnostic manufacturing
- Capabilities
- Real-Time PCR Assay Development · AltoStar Automation Platform · Global CE-IVD Distribution
- Founded
- 2007
- Headcount
- 201-500
- Company page (open ↗)
Clinical profileSTATUS: VERIFIED APRIL 2026
Soenke Friedrichsen
Managing Director (joint with Hans Kuhn)
Full addressMoerkenstrasse 12, 22767 Hamburg, Germany
Site coordinatesVerification evidence is still being completed.
Review cycle24 April 2026
Physical site source
Life Sciences Germany altona Diagnostics profile listing Moerkenstrasse 12 in Hamburg.
Open sourceCommercial CE-IVD diagnostic manufacturing
Hamburg, Germany. Molecular Diagnostics, Real-Time PCR Assays, and Global Infectious Disease Testing. Review completed on 24 Apr 2026.
BfArM and EU IVDR / FDA emergency-use oversight
ISO 13485 certification, CE-IVD assay approvals, Historical FDA EUA
Molecular Diagnostics, Real-Time PCR Assays, and Global Infectious Disease Testing
Hamburg molecular diagnostics manufacturer with named joint management, ISO 13485 certification, a broad CE-IVD assay portfolio, and a global subsidiary footprint across Americas and APAC.
Editorial note
altona Diagnostics strengthens the German diagnostics layer with a named joint management team, ISO 13485 certification, a CE-IVD assay portfolio spanning Ebola, SARS-CoV-2, dengue and arbovirus, HIV, and HBV/HCV, and a global subsidiary network.
FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleApril 2026
Capabilities
Core capabilities
Primary declared technical activities and areas of operating focus.
Real-Time PCR Assay Development
AltoStar Automation Platform
Global CE-IVD Distribution
Verification source dossier
Verification source dossier
Official source set used to support leadership, physical-site, certification, and watch-note evidence.
Infrastructure
Declared infrastructure
PCR assay manufacturing lines
AltoStar automation systems
QC and validation laboratories
Regulatory posture
Quality system coverage
GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.
- GMP
- REVIEW IN PROGRESS 2026
- GLP
- REVIEW IN PROGRESS 2026
- ISO-13485
- VERIFIED ACTIVE 2026
- FDA-Inspected
- VERIFIED ACTIVE 2026
Verification history
Verification history
24 Apr 2026: Executive identity confirmed via official management disclosure.
24 Apr 2026: Full trust review completed.
FAQ
Frequently asked questions
- Where is altona Diagnostics GmbH located?
- altona Diagnostics GmbH operates from Moerkenstrasse 12, 22767 Hamburg, Germany, Hamburg, Germany.
- Who runs altona Diagnostics GmbH?
- altona Diagnostics GmbH is led by Soenke Friedrichsen, Managing Director (joint with Hans Kuhn). Verified 24 Apr 2026.
- What certifications does altona Diagnostics GmbH hold?
- altona Diagnostics GmbH is documented under ISO 13485 certification, CE-IVD assay approvals, Historical FDA EUA.
- What does altona Diagnostics GmbH do?
- Hamburg molecular diagnostics manufacturer with named joint management, ISO 13485 certification, a broad CE-IVD assay portfolio, and a global subsidiary footprint across Americas and APAC. Core capabilities: Real-Time PCR Assay Development, AltoStar Automation Platform, Global CE-IVD Distribution.
Editorial context
Related technical briefs
Briefs that name Hamburg as a covered market or city.