Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medical Devices Pty Limited - Speculum, vaginal, single use
ARTG entry for
Medical Device Included Class Is
Medical Devices Pty Limited
PO Box 255,CONCORD, NSW, 2137
ARTG Start Date
Medical Device Class Is
- 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.
DTR Medical Ltd
17 Clarion Court Clarion Close
Swansea Enterprise Park, Swansea, SA6 8RF
1. Speculum, vaginal, single use
Single Device Product
37468 Speculum, vaginal, single use
This device is used during examination and treatment of the vagina for the purpose of providing access to
the interior by expanding adjustable blades thereby distending the opening to this orifice. This disposable
device is made of metal and is supplied sterile for single use.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 09:32:19 AEDT
This is not an ARTG Certificate document.
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