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Profusa Says It Received Positive Quality System Certification Decision From EU Certifier GMED; Lumee CE Mark Still Pending

Sep 24, 2026, 11:33 AMBenzinga Newsdesk

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BenzingaOct 15, 2026, 10:33 AMBenzinga Newsdesk
Profusa Secures Its ISO 13485:2016 Certificate From EU MDR Notified Body, GMED, Covering Lumee Oxygen Platform
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BenzingaSep 24, 2026, 6:02 PMVandana Singh
Micro Cap Profusa Navigates European Regulatory Hurdles to Advance Oxygen Monitoring Tech
Profusa received ISO 13485 certification from GMED, advancing its Lumee Oxygen Platform toward CE marking in the European Union.
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