Medical device licence · 85581 · Class 2
COBAS ACETAMINOPHEN CALIBRATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed March 23, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85581
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 23, 2011
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS ACETAMINOPHEN CALIBRATOR FOR USE ON ROCHE/HITACHI, COBAS C AND COBAS INTEGRA ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.