ApprovalTrail

Medical device licence · 90108 · Class 2

HEMOSEP SYSTEM

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed November 15, 2012; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
90108
Licence holder
Brightwake LimitedKirkby-In-Ashfield, NT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
November 15, 2012
Ended
October 31, 2018
Devices covered
8

Devices on this licence

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

  • HEMOSEP BLOOD COLLECTION BAG
  • HEMOSEP BLOOD RESERVOIR & INTERNAL PUMP
  • HEMOSEP CELL CONCENTRATOR
  • HEMOSEP CONCENTRATOR & BLOOD BAG
  • HEMOSEP INTRA-OPERATIVE KIT
  • HEMOSEP SHAKER
  • HEMOSEP SUCTION WAND AND TUBING
  • HEMOSEP SUCTION WAND SINGLE

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