Medical device licence · 84474 · Class 3
GEM HEMATOCRIT EVALUATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84474
- Licence holder
- Instrumentation Laboratory Co.Bedford, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- November 18, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEM HEMATOCRIT EVALUATOR 1
- GEM HEMATOCRIT EVALUATOR 2
- GEM HEMATOCRIT EVALUATOR 3
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.