ApprovalTrail

Medical device licence · 113528 · Class 3

AURORA

Yes: licensed in Canada

Licence status Issued (active); first licensed June 17, 2025. It is in Health Canada’s list of active licences.
Licence number
113528
Licence holder
Ge Medical Systems Israel, Functional ImagingTirat Hacarmel, Israel
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 17, 2025
Devices covered
1

Devices on this licence

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

  • AURORA

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