Medical device licence · 105553 · Class 2
AUDITORY NERVE TEST SYSTEM (ANTS)
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105553
- Licence holder
- Med-El Elektromedizinische Geraete GmbhInnsbruck, Austria
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 2, 2020
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTS CONNECTOR CABLE
- ANTS ELECTRODE
- STIMULATOR BOX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.