Medical device licence · 109349 · Class 2
SUBDERMAL NEEDLE ELECTRODES
Yes: licensed in Canada
Licence status Issued (active); first licensed May 17, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109349
- Licence holder
- Advantage Medical Electronics, LlcCoral Springs, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 17, 2023
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES
- DISPOSABLE SUBDERMAL NEEDLE ELECTRODES FOR IOM
- DISPOSABLE SUREPOINT SUBDERMAL NEEDLE ELECTRODES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.