Medical device licence · 104484 · Class 2
EASYSTAT ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104484
- Licence holder
- Medica CorporationBedford, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 24, 2020
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EASYBLOODGAS/EASYSTAT CAPILLARY TUBE KIT
- EASYQC HEMATOCRIT QUALITY CONTROL, BI-LEVEL
- EASYQC LEVEL 1 BLOOD GAS AND ELECTROLYTE QUALITY CONTROL
- EASYQC LEVEL 2 BLOOD GAS AND ELECTROLYTE QUALITY CONTROL
- EASYQC LEVEL 3 BLOOD GAS AND ELECTROLYTE QUALITY CONTROL
- EASYSTAT ANALYZER
- EASYSTAT CA++ ELECTRODE
- EASYSTAT EASYELECTROLYTES K+ ELECTRODE
- EASYSTAT EASYELECTROLYTES NA+ ELECTRODE
- EASYSTAT ECL- ELECTRODE
- EASYSTAT SAMPLER
- REAGENT MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.