Medical device licence · 80370 · Class 3
GEM PREMIER 3500 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 6, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80370
- Licence holder
- Instrumentation Laboratory Co.Bedford, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 6, 2009
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEM PREMIER 3500 SYSTEM - CVP (CALIBRATION VALIDATION PRODUCT)
- GEM PREMIER 3500 SYSTEM - INSTRUMENT
- GEM PREMIER 3500 SYSTEM - IQM BG/HCT PAK
- GEM PREMIER 3500 SYSTEM - IQM BG/LYTES
- GEM PREMIER 3500 SYSTEM - IQM BG/LYTES/GL PAK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.