Epocal epoc Blood Analysis System - HSA Registration DE0501024
Access comprehensive regulatory information for Epocal epoc Blood Analysis System in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0501024 and owned by Epocal Inc.. The device was registered on December 27, 2017.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or unanticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care. The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, pO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit.