ApprovalTrail

Medical device licence · 89543 · Class 2

GENTAMICIN TEST KIT

Yes: licensed in Canada

Licence status Issued (active); first licensed August 23, 2012. It is in Health Canada’s list of active licences.
Licence number
89543
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
August 23, 2012
Devices covered
1

Devices on this licence

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

  • GENT2 (ONLINE TDM GENTAMICIN)

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