ApprovalTrail

Medical device licence · 103013 · Class 3

GLUNEO PLUS

Yes: licensed in Canada

Licence status Issued (active); first licensed June 21, 2019. It is in Health Canada’s list of active licences.
Licence number
103013
Licence holder
Osang Healthcare Co., Ltd.Anyang-Si, GD, South Korea
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 21, 2019
Devices covered
3

Devices on this licence

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

  • GLUNEO PLUS BLOOD GLUCOSE MONITORING SYSTEM
  • GLUNEO PLUS BLOOD GLUCOSE TEST STRIPS
  • GLUNEO PLUS GLUCOSE CONTROL SOLUTION

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