Medical device licence · 111565 · Class 3
PTEYE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 23, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111565
- Licence holder
- Medtronic Xomed Inc.Jacksonville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 23, 2024
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PTEYE CONSOLE
- PTEYE CONSOLE REFURBISHED
- PTEYE PROBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.