Singapore HSA registration DE0501024
Epocal epoc Blood Analysis System
Singapore·CLASS C IVD·Epocal Inc.·Registered December 27, 2017Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0501024
- Registration Date
- December 27, 2017
- Change Notification Approval Date
- April 03, 2025
- Retention Due Date
- December 26, 2025
Product description
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.
Product Owner
- Name
- Epocal Inc.
- Short Name
- Epocal Inc.
- Address
- 2060 Walkley Road Ottawa, K1G 3P5, CANADA
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- epoc BGEM Test Card epoc NXS Host epoc Host2 epoc Reader epoc Reader (Refurbished) Eurotrol epoc Hematocrit Verification fluids Eurotrol Hct Control Level A Eurotrol Hct Control Level C Eurotrol Hct Control Level B Eurotrol epoc GAS-ISE Metabolites Level 1 Eurotrol epoc GAS-ISE Metabolites Level 2 Eurotrol epoc GAS-ISE Metabolites Level 3 Eurotrol epoc GAS-ISE Metabolites Level 6 Eurotrol epoc Calibration Verification Fluids epoc Care-Fill Capillary Tubes epoc BGEM Test Card epoc BGEM Test Card epoc Host2 epoc Reader
- Model Identifier(s)
- 10736515 11413518 11413528 11413750 11413817 190.000.005 195.002.010 195.003.010 195.004.010 266.001.010 266.002.010 266.003.010 266.006.010 267.000.005 AT-0006-00-00 CT-1004-00-00 CT-1006-00-00 HH-1009-00-00 HR-1002-00-00
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD