Medical device licence · 94472 · Class 3
FOCAL ONE
Yes: licensed in Canada
Licence status Issued (active); first licensed January 7, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94472
- Licence holder
- Edap Tms FranceVaulx-En-Velin, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group
- First licensed
- January 7, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FOCAL ONE
- FOCALPAK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.