ApprovalTrail

Medical device licence · 102395 · Class 2

CYTOSPONGE CELL COLLECTION DEVICE

Yes: licensed in Canada

Licence status Issued (active); first licensed February 12, 2019. It is in Health Canada’s list of active licences.
Licence number
102395
Licence holder
Covidien LlcChicopee, MA, United States
Risk class
Class II (low to moderate risk)
Licence type
Single Device
First licensed
February 12, 2019
Devices covered
2

Devices on this licence

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

  • CYTOSPONGE CELL COLLECTION DEVICE
  • CYTOSPONGE CELL COLLECTION KIT

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 “cytosponge”. 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.