ApprovalTrail

Medical device licence · 84883 · Class 3

HE4 EIA

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed January 12, 2011; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
84883
Licence holder
Fujirebio Diagnostics, Inc.Malvern, PA, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
January 12, 2011
Ended
December 9, 2025
Devices covered
1

Devices on this licence

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

  • HE4 EIA

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