Medical device licence · 38989 · Class 2
HCG STAT TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed July 24, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 38989
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 24, 2000
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS HCG STAT
- HCG STAT CALSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.