Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Starkey Laboratories Australia Pty Ltd - Hearing aid remote control
ARTG entry for
Medical Device Included Class 1
Starkey Laboratories Australia Pty Ltd
PO Box 7305,ALEXANDRIA, NSW, 2015
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.
Starkey Laboratories Inc
6600 Washington Avenue South
Eden Prairie, MN, 55344
United States Of America
1. Hearing aid remote control
Single Device Product
57885 Hearing aid remote control
A battery-powered device designed to be operated by the wearer of a hearing aid to enable discreet
wireless (remote) adjustments to the hearing aid (e.g., volume and program changes). It is designed to be
conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).
No Specific Conditions included on Record
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Produced at 03.11.2017 at 04:49:22 AEDT
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