ApprovalTrail

Medical device licence · 63614 · Class 2

MONOPOLAR NEEDLE ELECTRODE

Yes: licensed in Canada

Licence status Issued (active); first licensed January 27, 2004. It is in Health Canada’s list of active licences.
Licence number
63614
Licence holder
Rhythmlink International, LlcColumbia, SC, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
January 27, 2004
Devices covered
5

Devices on this licence

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

  • DETACHABLE MONOPOLAR EMG NEEDLE ELECTRODE
  • GROUND/REFERENCE NEEDLE ELECTRODE
  • LOW PROFILE EEG NEEDLE ELECTRODE
  • MONOPOLAR EMG NEEDLE ELECTRODE
  • PAIRED FINE WIRE MONOPOLAR NEEDLE ELECTRODE

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