Medical device licence · 72281 · Class 2
MEDIBYTE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 6, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72281
- Licence holder
- Braebon Medical CorporationKanata, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 6, 2006
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CTHERM CANNULA THERMISTOR FOR MEDIBYTE
- ELECTRODE BOX
- ELECTRODE BOX SE
- LEADWIRE KIT FOR MEDIBYTE
- MEDIBYTE
- MEDIBYTE ELECTRODE PREP KIT
- PERFORMANCE PLUS ECG DIAGNOSTIC ELECTRODES
- RIP BELT FOR MEDIBYTE
- SHORT LEADWIRE KIT FOR MEDIBYTE
- SNAP ELECTRODES
- SPO2 CABLE FOR MEDIBYTE, SOFT FINGERTIP
- ULTIMA SNORE MICROPHONE FOR MEDIBYTE WITH THERMISTOR INPUT
- USB CABLE FOR MEDIBYTE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.