Medical device licence · 113513 · Class 3
INVOS RSO2 PREAMPLIFIER
Yes: licensed in Canada
Licence status Issued (active); first licensed June 13, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113513
- Licence holder
- Covidien LlcChicopee, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 13, 2025
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INVOS ADULT RSO2 SENSOR
- INVOS INFANT REGIONAL SATURATION SENSOR
- INVOS PEDIATRIC RSO2 SENSOR
- INVOS REUSABLE INFANT SENSOR ADAPTER CABLE FOR PM7100
- INVOS REUSABLE SENSOR CABLE FOR PM7100
- INVOS RSO2 PREAMPLIFIER
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 “invos”. A notice may cover another product or only some lots: read it to see what it covers.
- Invos Reusable Sensor Cable For PM7100September 29, 2025 · Anaesthesiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.