ApprovalTrail

Medical device licence · 90403 · Class 3

RESTORELLE

No longer licensed: cancelled

Licence status Cancelled; first licensed December 28, 2012; ended March 2, 2023. It is in Health Canada’s archive of licences no longer in force.
Licence number
90403
Licence holder
Coloplast Corp.North Mankato, Minnesota, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
December 28, 2012
Ended
March 2, 2023
Devices covered
5

Devices on this licence

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

  • RESTORELLE L
  • RESTORELLE M
  • RESTORELLE XL
  • RESTORELLE Y
  • RESTORELLE Y CONTOUR

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 “restorelle”. 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.