Medical device licence · 28531 · Class 2
PROBES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 28531
- Licence holder
- Gentherm Medical, LlcCincinnati, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 18, 2001
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATTACHABLE SURFACE TEMPERATURE PROBE - REUSABLE
- BANJO SURFACE TEMPERATURE PROBE - REUSABLE
- CONNECTOR CABLE - REUSABLE
- ESOPHAGEAL RECTAL TEMPERATURE PROBE-PEDIATRIC
- STERI-PROBE RECTAL/ESOPHAGEAL TEMPERATURE PROBE - DISPOSABLE
- STERI-PROBE RECTAL/ESOPHAGEAL TEMPERATURE PROBE-REUSABLE
- STERI-PROBE SKIN TEMPERATURE PROBE - DISPOSABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.