Medical device licence · 113175 · Class 2
GUARDIAN NEEDLE ELECTRODE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 25, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113175
- Licence holder
- Rhythmlink International, LlcColumbia, SC, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- April 25, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GUARDIAN NEEDLES ARTIFACT FREE CT IMAGING
- GUARDIAN NEEDLES FOR CT IMAGING
- GUARDIAN NEEDLES FOR CT IMAGING FIXED DISTANCE PAIRED AND SINGLE
- PAIRED GUARDIAN NEEDLES FOR CT IMAGING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.