ApprovalTrail

Medical device licence · 80078 · Class 2

SYSMEX LINEARITY CONTROLS

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
80078
Licence holder
Sysmex CorporationKobe, Japan
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
June 30, 2009
Devices covered
8

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • WRP CHECK
  • WRP CHECK EX
  • XN CHECK
  • XN CHECK - L1
  • XN CHECK - L2
  • XN CHECK - L3
  • XN CHECK BF
  • XN-L CHECK

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.