Medical device licence · 64551 · Class 2
COCHLEAR INTEGRITY TEST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 19, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64551
- Licence holder
- Cochlear LimitedMacquarie Park, NSW, Australia
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 19, 2004
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COCHLEAR IMPLANT DIAGNOSTICS SYSTEM IMPLANT EMULATOR
- COCHLEAR IMPLANT DIAGNOSTICS SYSTEM SOFTWARE
- COCHLEAR INTEGRITY TEST SYSTEM
- COCHLEAR INTEGRITY TEST SYSTEM - INTEGRITY TEST UNIT
- COCHLEAR INTEGRITY TEST SYSTEM - SOFTWARE
- COCHLEAR INTEGRITY TEST SYSTEM - VERIFICATION UNIT
- NUCLEUS FREEDOM PROG CABLE
- NUCLEUS FREEDOM PROG SHOE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.