Miltenyi Biotec
Privately held German manufacturer of cell separation and cell therapy manufacturing technology.
Updated Jul 1, 2026
Headquartered in Germany
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Overview
About Miltenyi Biotec
Miltenyi Biotec manufactures cell separation, analysis, and cell and gene therapy manufacturing platforms used in research and clinical laboratories, and is a privately held manufacturer based in Bergisch Gladbach, Germany.
Products
- Cell separation & analysis systems
- Cell & gene therapy manufacturing platforms
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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Related
Regulatory Pathways
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