ApprovalTrail

Medical device licence · 95574 · Class 2

ACET2

Yes: licensed in Canada

Licence status Issued (active); first licensed August 13, 2015. It is in Health Canada’s list of active licences.
Licence number
95574
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
August 13, 2015
Devices covered
2

Devices on this licence

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

  • ACET2
  • ACET2 CALIBRATOR

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