ApprovalTrail

Medical device licence · 106175 · Class 3

CALF IMPLANTS

Yes: licensed in Canada

Licence status Issued (active); first licensed June 1, 2021. It is in Health Canada’s list of active licences.
Licence number
106175
Licence holder
Implantech Associates, Inc.Ventura, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
June 1, 2021
Devices covered
4

Devices on this licence

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

  • CONTOURFLEX CALF IMPLANT
  • CONTOURFLEX CALF IMPLANT SMOOTH (AIACHE STYLE)
  • CONTOURFLEX CALF IMPLANT SMOOTH (CARLSEN STYLE)
  • CONTOURFLEX CALF IMPLANT TEXTURED (AIACHE STYLE)

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