ApprovalTrail

Medical device licence · 95197 · Class 3

URETHRAL STENT SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed May 21, 2015; ended September 24, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
95197
Licence holder
Allium Ltd.Caesarea, Israel
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
May 21, 2015
Ended
September 24, 2018
Devices covered
3

Devices on this licence

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

  • BULBAR URETHRAL STENT (BUS) SYSTEM
  • ROUND POSTERIOR URETHRAL STENT (RPS) SYSTEM
  • TRIANGULAR PROSTATIC URETHRAL STENT (TPS) SYSTEM

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