Medical device licence · 98664 · Class 3
CK-MB
Yes: licensed in Canada
Licence status Issued (active); first licensed February 23, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98664
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 23, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALSET CK-MB
- CK-MB CALSET
- CK-MB STAT CALSET
- ELECSYS CK-MB
- ELECSYS CK-MB (STAT)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.