Medical device licence · 80511 · Class 3
PRIMER PLUS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 20, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80511
- Licence holder
- Bisco, Inc.Schaumburg, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- August 20, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- Z-PRIME PLUS
- Z-PRIME PLUS SAMPLE
- Z-PRIME PLUS UNITDOSE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.