Summary for ARTG Entry:
Cochlear Ltd - Stimulator, electrical, auditory, cochlea
ARTG entry for
Medical Device Included (Export Only) Class 1
1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109
ARTG Start Date
Medical Device Class 1
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
1 University Avenue
MACQUARIE UNIVERSITY, NSW, 2109
1. Stimulator, electrical, auditory, cochlea
Single Device Product
35643 Stimulator, electrical, auditory, cochlea
The Nucleus 24 Cochlear Implant CI24RE(CA) is intended to restore a level of auditory sensation via
electrical stimulation of the auditory nerve in adults and children. The cochlear implant is part of a System,
consisting of an implant, connected to a receiver-stimulator that is implanted in the skull near the ear, and
a speech processor that is worn externally which converts sound into electrical signals to be transmitted to
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:32:10 AEDT
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