ApprovalTrail

Medical device licence · 93443 · Class 2

DR 400

Yes: licensed in Canada

Licence status Issued (active); first licensed June 19, 2014. It is in Health Canada’s list of active licences.
Licence number
93443
Licence holder
Agfa N.V.Mortsel, Belgium
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
June 19, 2014
Devices covered
3

Devices on this licence

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

  • DR 400
  • WS-MANUAL-001
  • WS-MANUAL-T-001

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