Medical device licence · 100597 · Class 2
RONDO 2 AUDIO PROCESSOR
Yes: licensed in Canada
Licence status Issued (active); first licensed February 16, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100597
- Licence holder
- Med-El Elektromedizinische Geraete GmbhInnsbruck, Austria
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 16, 2018
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FINETUNER
- FINETUNER + OPENING TOOL
- FINETUNER EXTENSION KIT
- MAX PROGRAMMING CABLE RONDO 2
- MBP CABLE FOR RONDO 2
- MBP MTD CONNECTING CABLE
- MICROPHONE TEST DEVICE
- MINI BATTERY PACK
- RONDO 2 AUDIO PROCESSOR ME1150
- RONDO 2 PROCESSOR UNIT SP
- RONDO 2 SOCKET SEAL
- SPEECH PROCESSOR TEST DEVICE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.