ApprovalTrail

Medical device licence · 79846 · Class 2

LEAD WIRES FOR ECG MACHINES

Yes: licensed in Canada

Licence status Issued (active); first licensed May 29, 2009. It is in Health Canada’s list of active licences.
Licence number
79846
Licence holder
Spacelabs Healthcare Ltd. (Hertford)Hertford, HT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
May 29, 2009
Devices covered
11

Devices on this licence

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

  • 10 ELECTRODE LEAD WIRES
  • 11 ELECTRODE LEAD WIRES
  • 12 LEAD WIRE
  • ARIA LEAD WIRES
  • CABLE, PATIENT, LC12
  • CARDIOEXPRESS LEAD WIRES
  • ECLIPSE PRO, CABLE, PX
  • EVO LEAD WIRES
  • LIFECARD CF LEAD WIRES
  • PATIENT CABLE 2 CHANNEL, RED/YEL/GRN
  • PATIENT CABLE SINGLE CHANNEL US

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