Medical device licence · 102691 · Class 3
CARESCAPE ONE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 11, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102691
- Licence holder
- Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 11, 2019
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARESCAPE DOCK F0
- CARESCAPE ECG
- CARESCAPE ECG NEONATAL INTENSIVE CARE (NICU) TRUNK CABLE
- CARESCAPE ONE
- CARESCAPE PRES
- CARESCAPE SPO2
- CARESCAPE TEMP
- ECG LEADWIRE SETS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.