ApprovalTrail

Medical device licence · 96002 · Class 2

PROGESTERONE

Yes: licensed in Canada

Licence status Issued (active); first licensed October 27, 2015. It is in Health Canada’s list of active licences.
Licence number
96002
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
October 27, 2015
Devices covered
4

Devices on this licence

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

  • ELECSYS PROGESTERONE DILUENT
  • ELECSYS PROGESTERONE III
  • PROGESTERONE III CALCHECK5
  • PROGESTERONE III CALSET

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