ApprovalTrail

Medical device licence · 7489 · Class 2

HYSTEROSALPINGOGRAPHY/SALPINGOGRAPHY

Yes: licensed in Canada

Licence status Issued (active); first licensed July 8, 1999. It is in Health Canada’s list of active licences.
Licence number
7489
Licence holder
Cook, IncorporatedBloomington, IN, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
July 8, 1999
Devices covered
4

Devices on this licence

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

  • COOK SILICONE BALLOON HSG CATHETER
  • GOLDSTEIN SONOHYSTEROGRAPHY CATHETER SET
  • INTRAUTERINE ACCESS BALLOON CATHETER
  • MARGOLIN HSG CANNULA

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