Medical device licence · 105898 · Class 2
RONDO 3 KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 1, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105898
- Licence holder
- Med-El Elektromedizinische Geraete GmbhInnsbruck, Austria
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- March 1, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RONDO 3 (AXIAL) USER KIT
- RONDO 3 (DIAM) USER KIT
- RONDO 3 ME1550 (AXIAL) CORE USER KIT
- RONDO 3 ME1550 (DIAMETRAL) CORE USER KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.