ApprovalTrail

Medical device licence · 74396 · Class 3

CHEMISTRY ANALYZERS

Yes: licensed in Canada

Licence status Issued (active); first licensed July 4, 2007. It is in Health Canada’s list of active licences.
Licence number
74396
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
July 4, 2007
Devices covered
2

Devices on this licence

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

  • COBAS C 111 STAND ALONE CONFIGURATION
  • COBAS C 111 WITH ISE STAND ALONE CONFIGURATION

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