Medical device licence · 108239 · Class 3
X-CUBE 60
Yes: licensed in Canada
Licence status Issued (active); first licensed September 7, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108239
- Licence holder
- Alpinion Medical Systems Co., Ltd.Seoul, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 7, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PENCIL DOPPLER
- TRANSDUCER
- X-CUBE 60 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.