ApprovalTrail

Medical device licence · 6472 · Class 2

HOLTER RECORDERS

Yes: licensed in Canada

Licence status Issued (active); first licensed June 26, 1999. It is in Health Canada’s list of active licences.
Licence number
6472
Licence holder
Spacelabs Healthcare Ltd. (Hertford)Hertford, HT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
June 26, 1999
Devices covered
5

Devices on this licence

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

  • ECLIPSE MINI DIAGNOSTIC PATCH RECORDER
  • ECLIPSE PRO AMBULATORY ECG AND PATCH RECORDER
  • EVO SYSTEM - MONITOR
  • LIFECARD 12 RECORDER
  • LIFECARD CF

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