Medical device licence · 95201 · Class 3
INFA WARMER I
Yes: licensed in Canada
Licence status Issued (active); first licensed May 25, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95201
- Licence holder
- Atom Medical CorporationSaitama-Shi, 11, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 25, 2015
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLENDER UNIT
- CONNECTING CABLE FOR DISPO SKIN TEMP PROBE
- DISPO SKIN TEMP PROBE
- INCU I TESTER
- INFA WARMER I - ATOM INFANT WARMER MODEL 103
- PATIENT CIRCUIT
- POWER PACK I
- RESUSCITATION UNIT
- 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.