Medical device licence · 95937 · Class 3
DUAL INCU I
Yes: licensed in Canada
Licence status Issued (active); first licensed October 15, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95937
- Licence holder
- Atom Medical CorporationSaitama-Shi, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 15, 2015
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONNECTING CABLE FOR DISPO SKIN TEMP PROBE
- DISPO SKIN TEMP PROBE
- DUAL INCU I - ATOM INFANT INCUBATOR MODEL 100
- INCU I TESTER
- OXYGEN SENSOR
- PNEUMOCLEAN ELECTROSTATIC FILTER
- POWER PACK I
- SKIN TEMP PROBE
- SPO2 UNIT
- WEIGHT MONITOR UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.