ApprovalTrail

Medical device licence · 99713 · Class 2

VAGINAL PESSARIES

Yes: licensed in Canada

Licence status Issued (active); first licensed September 21, 2017. It is in Health Canada’s list of active licences.
Licence number
99713
Licence holder
Medgyn Products International Inc And Medgyn Products, Inc.Westmont, IL, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
September 21, 2017
Devices covered
8

Devices on this licence

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

  • MEDGYN PESSARY GELLHORN W/DRAIN
  • MEDGYN PESSARY SILICONE DONUT
  • PESSARY CUBE W/DRAIN
  • PESSARY CUBE W/O DRAIN
  • PESSARY GEHRUNG W/SUPPORT
  • PESSARY GELLHORN WITH DRAIN, SHORT STEM
  • PESSARY MARLAND W/O SUPPORT
  • PESSARY MARLAND W/SUPPORT

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