Medical device licence · 78254 · Class 3
SONOLITH I-SYS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 27, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78254
- Licence holder
- Edap Tms FranceVaulx-En-Velin, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- October 27, 2008
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SONOLITH I-SYS SYSTEM
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “sonolith”. A notice may cover another product or only some lots: read it to see what it covers.
- Sonolith i-sys System (2019-01-17)March 8, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.