ApprovalTrail

Medical device licence · 13806 · Class 2

PREMICATH

Yes: licensed in Canada

Licence status Issued (active); first licensed November 1, 1999. It is in Health Canada’s list of active licences.
Licence number
13806
Licence holder
Vygon Corporation D.B.A. Vygon UsaEcouen, France
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
November 1, 1999
Devices covered
3

Devices on this licence

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

  • PREMICATH 28GA WITH PEELABLE CANNULA
  • PREMICATH, 28G WITH SPLIT CANNULA INTRODUCER
  • PREMICATH, 28G WITH SPLITTING NEEDLE

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