Medical device licence · 78587 · Class 3
FETAL & MATERNAL MONITORS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 4, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78587
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 4, 2008
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3-LEAD ECG CABLE
- DECG CABLE
- F6 FETAL & MATERNAL MONITOR
- F9 FETAL & MATERNAL MONITOR
- FETAL TELEMETRY SYSTEM
- IUP CONNECTING CABLE
- NIBP CUFF
- NIBP CUFF EXTENSION TUBE
- REMOTE EVENT MARKER
- SPO2 SENSOR
- TEMPERATURE PROBE
- TOCO TRANSDUCER
- US TRANSDUCER
- WIRELESS TOCO TRANSDUCER
- WIRELESS US TRANSDUCER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.