Medical device licence · 105899 · Class 2
RONDO 3 AUDIO PROCESSOR
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
- 105899
- Licence holder
- Med-El Elektromedizinische Geraete GmbhInnsbruck, Austria
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 1, 2021
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUDIOSTREAM & TELECOIL ADAPTERS
- AUDIOSTREAM & TELECOIL ADPTERS EXTENSION KIT
- AUDIOSTREAM ADAPTER & CASE
- AUDIOSTREAM ADAPTER EXTENSION KIT
- AUDIOSTREAM ADAPTER KIT
- CHARGING CABLE
- FINETUNER ECHO +BATTERY
- MAX PROG. CABLE RONDO 2
- MBP & RONDO 3 MBP CABLE
- MINI BATTERY PACK ANTHRACITE
- MINI BATTERY PACK FOR RONDO 3
- RONDO 3 (AXIAL)
- RONDO 3 (DIAM)
- RONDO 3 CLINICAL KIT
- RONDO 3 MBP CABLE
- RONDO 3 PROCESSOR UNIT
- RONDO 3 TELECOIL ADAPTER & CASE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.