Medical device licence · 94954 · Class 2
MOUTHPIECES
Yes: licensed in Canada
Licence status Issued (active); first licensed March 27, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94954
- Licence holder
- Intersurgical Ltd.East Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 27, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEXIBLE BITE-GRIP MOUTHPIECE
- RESMED EASYSPEAK ANGLED NIV MOUTHPIECE
- RESMED EASYSPEAK MOUTHPIECE, ANGLED
- RESMED EASYSPEAK MOUTHPIECE, ANGLED W/ TUBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.