ApprovalTrail

Medical device licence · 14100 · Class 2

URODYNAMIC CATHETERS

Yes: licensed in Canada

Licence status Issued (active); first licensed November 8, 1999. It is in Health Canada’s list of active licences.
Licence number
14100
Licence holder
Laborie Medical Technologies, Corp.Portsmouth, NH, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
November 8, 1999
Devices covered
14

Devices on this licence

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

  • 2-LUMEN CATHETER FOR CYSTOMETRY AND URETHRAL
  • 2-LUMEN MULTI-POINT CATHETER FOR CYSTOMETRY AND URETHRAL PRESSURE
  • 3-LUMEN CATHETER
  • BLADDER FILLING CATHETER
  • BLADDER PRESSURE CATHETER
  • COUDE DUAL LUMEN CATHETER
  • COUDE TRIPLE LUMEN CATHETER
  • DOUBLE-LUMEN CATHETER FOR FILLING AND CYSTOMANOMETRY
  • DUAL LUMEN CATHETER
  • RECTAL BALLOON CATHETER FOR INTRALUMINAL PRESSURE
  • TRIPLE LUMEN URODYNAMIC CATHETER FOR CYSTOMETRY
  • TRIPLE-LUMEN CATHETER FOR FILLING AND CYSTOMANOMETRY
  • TWIN LUMEN URODYNAMIC CATHETER FOR CYSTOMETRY
  • UPP URETHRAL PRESSURE PROFILOMETRY CATHETER

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