ApprovalTrail

Medical device licence · 21479 · Class 4

ES SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed June 14, 2000; ended October 31, 2000. It is in Health Canada’s archive of licences no longer in force.
Licence number
21479
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class IV (highest risk)
Licence type
System
First licensed
June 14, 2000
Ended
October 31, 2000
Devices covered
8

Devices on this licence

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

  • ES SYSTEM - ANTI-HBC
  • ES SYSTEM - ANTI-HBC IGM
  • ES SYSTEM - ANTI-HBS
  • ES SYSTEM - ES300 ANALYZER - CLASS 4
  • ES SYSTEM - HBEAG/ANTI-HBE
  • ES SYSTEM - HBSAG II
  • ES SYSTEM - HBSAG III
  • ES SYSTEM - HBSAG(CONFIRMATORY)

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