Medical device licence · 108013 · Class 2
CYFLOW CD33
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108013
- Licence holder
- Sysmex Partec GmbhGoerlitz, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 15, 2022
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CYFLOW CD33 APC
- CYFLOW CD33 FITC
- CYFLOW CD33 PE
- CYFLOW CD33 PE-CY7
- CYFLOW CD33 PERCP-CY5.5
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.