Medical device licence · 84473 · Class 3
GEM SYSTEM 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
- 84473
- 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 SYSTEMS EVALUATOR 1
- GEM SYSTEMS EVALUATOR 2
- GEM SYSTEMS EVALUATOR 3
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.