ApprovalTrail

Medical device licence · 83538 · Class 2

ENDOFLIP SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed August 4, 2010. It is in Health Canada’s list of active licences.
Licence number
83538
Licence holder
Covidien LlcChicopee, MA, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 4, 2010
Devices covered
4

Devices on this licence

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

  • ENDOFLIP CATHETER W/PRESSURE MEASUREMENT
  • ENDOFLIP LOCALISATION KIT
  • ENDOFLIP POWER SUPPLY
  • ENDOFLIP SYSTEM

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

  • Endoflip SystemMay 14, 2026 · Gastroenterology and urology · Performance · Type I

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