ApprovalTrail

Medical device licence · 107327 · Class 3

MONACO

Yes: licensed in Canada

Licence status Issued (active); first licensed January 31, 2022. It is in Health Canada’s list of active licences.
Licence number
107327
Licence holder
Elekta Solutions AbStockholm, Sweden
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
January 31, 2022
Devices covered
1

Devices on this licence

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

  • MONACO

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 “monaco”. A notice may cover another product or only some lots: read it to see what it covers.

  • MonacoMarch 2, 2023 · Radiology · Performance · Type II

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