ApprovalTrail

Medical device licence · 81527 · Class 3

GLUCOSE 201 DM SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 21, 2009. It is in Health Canada’s list of active licences.
Licence number
81527
Licence holder
Hemocue AbAngelholm, Sweden
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 21, 2009
Devices covered
2

Devices on this licence

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

  • GLUCOSE 201 DM ANALYZER SYSTEM - MICROCUVETTES
  • GLUCOSE 201 DM ANALYZER SYSTEM - MMOL/L INSTRUMENT

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