Medical device licence · 102241 · Class 2
HSG CATHETER
Yes: licensed in Canada
Licence status Issued (active); first licensed January 8, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102241
- 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
- January 8, 2019
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EZ INJECT CATHETER RIGID STERILE
- HS CATHETER -5FR
- HS CATHETER -7FR
- HSG CATHETER (5F)
- HSG CATHETER (7F)
- HSG KIT WITHOUT HSG
- HSG KIT, 5FR + TRAY COMBO, FLEXIBLE
- HSG KIT, 5FR + TRAY COMBO, SHAPEABLE
- HSG KIT, 7FR + TRAY COMBO, FLEXIBLE
- HSG KIT, 7FR + TRAY COMBO, SHAPEABLE
- K-UMI MANIPULATOR
- MILLER ADVANCE CATHETER
- SHAPEABLE HS CATHETER - 5FR
- SHAPEABLE HS CATHETER - 7FR
- UMI - UTERINE MANIPULATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.