Medical device licence · 80076 · Class 2
SYSMEX HEMATOLOGY REAGENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 30, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80076
- Licence holder
- Sysmex CorporationKobe, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 30, 2009
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CELLPACK
- CELLPACK DCL
- CELLPACK DFL
- CELLPACK DST
- CELLPACK-S
- CELLSHEATH
- CELLSHEATH CCS
- FLUOROCELL PLT
- FLUOROCELL RET
- FLUOROCELL WDF
- FLUOROCELL WNR
- FLUOROCELL WPC
- LYSERCELL WDF
- LYSERCELL WNR
- LYSERCELL WPC
- STROMATOLYSER
- SULFOLYSER
- SULFOLYSER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.