ApprovalTrail

Medical device licence · 11243 · Class 3

UNIVERSAL OSSICULAR RECONSTRUCTION IMPLANTS, FLEX H/A

Yes: licensed in Canada

Licence status Issued (active); first licensed September 2, 1999. It is in Health Canada’s list of active licences.
Licence number
11243
Licence holder
Medtronic Xomed Inc.Jacksonville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
September 2, 1999
Devices covered
3

Devices on this licence

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

  • BOJRAB FLEX H/A UNIVERSAL PROSTHESIS
  • UNIVERSAL H/A PROSTHESIS
  • UNIVERSAL OSSICULAR RECONSTRUCTION IMLANTS - GARCIA-IBANEZ FLEX H/A UNIV.

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