Medical device licence · 101353 · Class 3
ISOLETTE 8000 PLUS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101353
- Licence holder
- Draeger Medical Systems, Inc.Danvers, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 5, 2018
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ISOLETTE 8000 PLUS
- PROBE, WHITE, PERIPHERAL SKIN TEMPERATURE, DISPOSABLE
- PROBE, YELLOW, CENTRAL SKIN TEMPERATURE, DISPOSABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.