Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Orthopaedic Appliances Pty Ltd - Prosthesis, external, arm, <specify>
ARTG entry for
Medical Device Included Class 1
Orthopaedic Appliances Pty Ltd
29 South Corporate Avenue, ROWVILLE, VIC, 3178
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
- 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.
Regal Prosthesis Ltd
Room D 3/F Mai Luen Industrial Building 23-31
Kung Yip Street
Kwai Chung, New Territories,
Hong Kong - SAR of China
1 . Prosthesis, external, arm, <specify>
Single Device Product
41485 Prosthesis, external, arm, <specify>
Cosmetic Protective covering for Prosthetic upper limb.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 09:05:42 AEST
This is not an ARTG Certificate document.
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