Medical device licence · 88686 · Class 2
SYSMEX HEMATOLOGY CALIBRATORS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 17, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 88686
- Licence holder
- Sysmex CorporationKobe, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 17, 2012
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- X-CAL
- XN CAL
- XN CAL - CUSTOMER SET
- XN CAL - FSR SET
- XN CAL PF
- XN CAL PF - CUSTOMER SET
- XN CAL PF - FSR SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.