Medical device licence · 82419 · Class 3
VOICE PROSTHESIS WITH INSERTION DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 31, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82419
- Licence holder
- Atos Medical AbHorby, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- March 31, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROVOX VEGA (WITH PROVOX INSERTION SYSTEM)
- PROVOX VEGA XTRASEAL (WITH PROVOX INSERTION SYSTEM)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.