Summary for ARTG Entry:
Ausai Pty Ltd - Condom, male, latex, lubricated
ARTG entry for
Medical Device Included Class IIb
Ausai Pty Ltd
9 Forestlea Place,SUNNYBANK HILLS, QLD, 4109
ARTG Start Date
Medical Device Class IIb
- 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.
Dong Tai BioMed Industrial Co Ltd
No 1 Second Hailong Road Dongtai Coastal
, Jiangsu Province, 224237
1. Condom, male, latex, lubricated
Single Device Product
45137 Condom, male, latex, lubricated
A device that is a latex rubber sheath worn to cover the penis during coitus to prevent sperm from gaining
access to the female reproductive tract and/or prevent microorganisms, e.g., those that cause sexually
transmitted diseases, from being transmitted from one user to another. The device is provided with a
compatible lubricant. This is a single-use device.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:25:50 AEDT
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