ApprovalTrail

Medical device licence · 13454 · Class 2

DILATOR(S) CATHETER(S)

Yes: licensed in Canada

Licence status Issued (active); first licensed October 29, 1999. It is in Health Canada’s list of active licences.
Licence number
13454
Licence holder
Integra Lifesciences Production CorporationMansfield, MA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
October 29, 1999
Devices covered
6

Devices on this licence

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

  • CATHETER FEMALE
  • HANK UTERINE DILATORS
  • HEGAR DILATOR
  • OS CERVICAL DILATOR SET
  • PRATT UTERINE DILATOR
  • WALTHER FEMALE DIL-CATH

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