ApprovalTrail

Medical device licence · 79188 · Class 3

ARTIS DIALYSIS SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed March 6, 2009. It is in Health Canada’s list of active licences.
Licence number
79188
Licence holder
Gambro Dasco S.P.A.Medolla, MO, Italy
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 6, 2009
Devices covered
3

Devices on this licence

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

  • ARTIS 115V PHYSIO II (SW 8.6)
  • ARTIS DIALYSIS SYSTEM
  • ARTIS DIALYSIS SYSTEM - SOFTWARE

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