Medical device licence · 79357 · Class 3
EPOC BLOOD ANALYSIS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 23, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79357
- Licence holder
- Epocal Inc.Ottawa, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 23, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EPOC BLOOD ANALYSIS BGEM TEST CARDS
- EPOC BLOOD ANALYSIS SYSTEM - COMPUTING DEVICE WITH CUSTOM SOFTWARE
- EPOC BLOOD ANALYSIS SYSTEM - SINGLE USE BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
- EPOC BLOOD ANALYSIS SYSTEM - TEST CARD READER
- EPOC NXS HOST - 0000
- EPOC NXS HOST - 4D58MX
- EPOC NXS HOST - 544DROW
- EPOC NXS HOST - 5553CA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.