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Sources: EU EUDAMED, US FDA
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Country: Canada
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epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
FDA Enforcement
Class II
·Terminated·Epocal Inc·July 25, 2012
Epocal Inc.
Manufacturer
🇨🇦 Canada·2 Importers·TÜV Rheinland LGA Products GmbH
Epocal Inc.
Manufacturer
🇨🇦 Canada·2 Importers
HX 2262557-1
Certificate
IVDR QMS·Epocal Inc.·TÜV Rheinland LGA Products GmbH
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013