ApprovalTrail

Medical device licence · 106495 · Class 3

SOFIA

No longer licensed: cancelled

Licence status Cancelled; first licensed August 11, 2021; ended June 10, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
106495
Licence holder
Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 11, 2021
Ended
June 10, 2025
Devices covered
3

Devices on this licence

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

  • INSTALLATION PACK
  • SOFIA
  • SOFIA (REFURBISHED)

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