Medical device licence · 103554 · Class 2
AMIK2
Yes: licensed in Canada
Licence status Issued (active); first licensed September 6, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103554
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- September 6, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMIK2 (ONLINE TDM AMIKACIN)
- AMIK2 ONLINE TDM AMIKACIN FOR COBAS C SYSTEMS
- AMIKACIN (AMIK2) FOR USE ON COBRAS C SYSTEMS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.