ApprovalTrail

Medical device licence · 101547 · Class 2

TISSUE MIMICKING MATERIAL

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 2, 2018; ended October 17, 2022. It is in Health Canada’s archive of licences no longer in force.
Licence number
101547
Licence holder
Sun Nuclear CorporationMiddleton, WI, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 2, 2018
Ended
October 17, 2022
Devices covered
22

Devices on this licence

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

  • AP6 FAT
  • B200 BONE MINERAL
  • BR12 BREAST
  • BRN-SR2 BRAIN
  • CB2 + 10% CAC03
  • CB2 + 30% CAC03
  • CB2 + 50% CAC03
  • HE BLOOD
  • HE BRAIN
  • HE BREAST 50:50
  • HE BREAST ADIPOSE
  • HE BREAST GLANDULAR
  • HE CORTICAL BONE
  • HE GENERAL ADIPOSE
  • HE INNER BONE
  • HE LIVER
  • IB3 INNER BONE
  • LN 450 LUNG
  • LN-300 LUNG
  • LV1 LIVER
  • MS11 MUSCLE
  • SB3 CORTICAL BONE

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