ApprovalTrail

Medical device licence · 85193 · Class 2

HOLTER SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed February 17, 2011. It is in Health Canada’s list of active licences.
Licence number
85193
Licence holder
Edan Instruments, Inc.Shenzhen, 190, China
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
February 17, 2011
Devices covered
1

Devices on this licence

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

  • HOLTER SYSTEM

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