Summary for ARTG Entry:
Livingstone International Pty Ltd - Burn gel, sterile
ARTG entry for
Medical Device Included Class IIa
Livingstone International Pty Ltd
106-116 Epsom Road,ROSEBERY, NSW, 2018
ARTG Start Date
Medical Device Class IIa
- 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.
Roosin Medical Co Ltd
No 8 Yuandong Road Kouan Town Gaogang
Jiangsu Province, , 225321
1. Burn gel, sterile
Single Device Product
47694 Burn gel, sterile
A sterile substance intended to be applied directly to a minor burn or sunburn. It is usually designed to
protect against infection, minimize trauma and skin damage, provide pain relief, moisten and cool the burn
area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel
or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in
the home. After application, this device cannot be reused.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:10:55 AEDT
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