Medical device licence · 87035 · Class 2
OPIATES
Yes: licensed in Canada
Licence status Issued (active); first licensed August 26, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87035
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 26, 2011
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPI2 (OPIATES II)
- OPIATES 300/200
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.