Medical device licence · 84458 · Class 2
SPO2 SENSOR
Yes: licensed in Canada
Licence status Issued (active); first licensed November 17, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84458
- Licence holder
- Unimed Medical Supplies, Inc.Shenzhen, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 17, 2010
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISPOSABLE ADHESIVE TEXTILE SPO2 SENSORS
- INFANT SOFT TIP SENSOR
- REUSABLE ADULT EAR CLIP SPO2 SENSOR
- REUSABLE ADULT FINGER CLIP SPO2 SENSOR
- REUSABLE ADULT SOFT TIP SPO2 SENSOR
- REUSABLE ADULT/NEONATE WRAP SPO2 SENSORS
- REUSABLE INFANT SOFT TIP SPO2 SENSOR
- REUSABLE MULTI-SITE Y-SHAPE SPO2 SENSOR
- REUSABLE NEONATE WRAP SPO2 SENSOR
- REUSABLE PEDIATRIC FINGER CLIP SPO2 SENSOR
- REUSABLE PEDIATRIC SOFT TIP SPO2 SENSOR
- REUSABLE PEDIATRIC/INFANT WRAP SPO2 SENSOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.