Medical device licence · 94538 · Class 2
I-PEN
Yes: licensed in Canada
Licence status Issued (active); first licensed January 15, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94538
- Licence holder
- I-MED Pharma, Inc.Pointe-Claire, Quebec, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 15, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- I-PEN
- I-PEN SINGLE USE SENSOR (SUS)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.