Siemens Healthineers
Global medical imaging and diagnostics manufacturer headquartered in Erlangen, Germany.
Updated Jul 1, 2026
Headquartered in Erlangen, Germany
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Overview
About Siemens Healthineers
Siemens Healthineers is headquartered in Erlangen, Germany, and publicly traded on the Frankfurt Stock Exchange, majority-owned by Siemens AG. It manufactures medical imaging systems, in-vitro diagnostics, and — through its Varian subsidiary — radiotherapy equipment, ranking among the largest medical technology companies in the world.
Products
- MRI & CT imaging systems
- Laboratory diagnostics (Atellica platform)
- Radiotherapy & radiation oncology equipment (Varian)
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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EU MDR
The EU regulation that defines medical device requirements — CE Marking is the certification mark it produces once satisfied.
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IVDR
The EU regulation governing in vitro diagnostic devices — the IVD counterpart to the MDR.
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Related
Regulatory Pathways
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