ApprovalTrail

Medical device licence · 81467 · Class 2

URETERAL STENT SET

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed December 11, 2009; ended July 9, 2015. It is in Health Canada’s archive of licences no longer in force.
Licence number
81467
Licence holder
Gallini S.R.L.Mantova, MO, Italy
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
December 11, 2009
Ended
July 9, 2015
Devices covered
10

Devices on this licence

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

  • FLEXASOFT MULTILENGHT URETERAL STENT SET
  • FLEXASOFT PAEDIATRIC URETERAL STENT SET
  • FLEXASOFT PROBING URETERAL STENT SET
  • FLEXASOFT URETERAL STENT SET
  • FLEXASOFT URETERAL STENT SET PERCUTANEOUS PLACEMENT TECHNIQUE
  • FLEXASOFT URETERAL STENT SET STANDARD PLACEMENT TECHNIQUE
  • FLEXASOFT URETEROTOMY STENT SET
  • FLEXATER MONOPIGTAIL SET
  • FLEXATER STEERABLE URETERAL STENT SET
  • FLEXATER URETERAL STENT SET

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