Medical device licence · 22773 · Class 2
SYSMEX HEMATOLOGY ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 8, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 22773
- Licence holder
- Sysmex CorporationKobe, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 8, 2000
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SYSMEX KX-21 ANALYZER
- SYSMEX XE-2100 ANALYZER
- SYSMEX XE-ALPHA ANALYZER
- SYSMEX XT-1800I ANALYZER
- XE-2100C HEMATOLOGY ANALYZER
- XE-2100DC HEMATOLOGY ANALYZER
- XE-5000 HEMATOLOGY ANALYZER
- XN-10 MODULE
- XN-11 MODULE
- XN-20 MODULE
- XN-L SERIES
- XS-1000I, HEMATOLOGY ANALYZER
- XS-1000IC HEMATOLOGY ANALYZER
- XT-2000I ANALYZER
- XT-4000I HEMATOLOGY ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.