Medical device licence · 107909 · Class 3
COOLTONE
Yes: licensed in Canada
Licence status Issued with conditions; first licensed June 30, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107909
- Licence holder
- Zimmer Medizinsysteme GmbhNeu-Ulm, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 30, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COOLTONE APPLICATOR
- COOLTONE SECUREMENT SYSTEM
- COOLTONE SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.