Medical device licence · 107963 · Class 2
CYFLOW CD34
Yes: licensed in Canada
Licence status Issued (active); first licensed July 8, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107963
- Licence holder
- Sysmex Partec GmbhGoerlitz, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 8, 2022
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CYFLOW CD34 APC
- CYFLOW CD34 PE
- CYFLOW CD34 PE-DYLIGHT 594
- CYFLOW CD34 PERCP-CY5.5
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.