ApprovalTrail

Medical device licence · 109483 · Class 3

XTREMECT II

Yes: licensed in Canada

Licence status Issued (active); first licensed June 12, 2023. It is in Health Canada’s list of active licences.
Licence number
109483
Licence holder
Scanco Medical AgBruettisellen, ZH, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 12, 2023
Devices covered
1

Devices on this licence

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

  • XTREMECT II

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

  • XtremeCTJuly 31, 2025 · Radiology · Performance · Type II

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