Summary for ARTG Entry:
Werfen Australia Pty Ltd - Treponema (syphilis) IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Werfen Australia Pty Ltd
59 - 61 Dickson Avenue,ARTARMON, NSW, 2064
ARTG Start Date
Medical Device Class 3
- 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.
Can Male s/n 08186 Llica Damunt
1. Treponema (syphilis) IVDs
CT799 Treponema (syphilis) IVDs
IVDs that are intended to be used in testing to provide information about infection with or exposure to
Treponema bacteria, the spirochete bacteria associated with syphilis.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:41:16 AEDT
This is not an ARTG Certificate document.
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