Medical device licence · 107043 · Class 2
DXU 810C IRIS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 26, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107043
- Licence holder
- Beckman Coulter Ireland, Inc.Co. Clare, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 26, 2021
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DXU 810C IRIS
- ICHEM VELOCITY CALCHEK KIT
- ICHEM VELOCITY URINE CHEMISTRY STRIPS
- ICHEM VELOCITY WASH SOLUTION
- ICHEMVELOCITY URINE CHEMISTRY DESICCANT
- IRISPEC CA/CB/CC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.