ApprovalTrail

Medical device licence · 102421 · Class 3

FILMARRAY TORCH

Yes: licensed in Canada

Licence status Issued (active); first licensed February 19, 2019. It is in Health Canada’s list of active licences.
Licence number
102421
Licence holder
Biofire Diagnostics, Llc.Salt Lake City, UT, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 19, 2019
Devices covered
3

Devices on this licence

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

  • FILMARRAY TORCH DUPLEX
  • FILMARRAY TORCH MODULE
  • FILMARRAY TORCH SYSTEM BASE

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “filmarray”. A notice may cover another product or only some lots: read it to see what it covers.

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