Speculum, vaginal, single use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Medical Devices Pty Limited
Class:
Class Is
Authorization status:
Included
Authorization number:
292285

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Public Summary

Summary for ARTG Entry:

292285

Medical Devices Pty Limited - Speculum, vaginal, single use

ARTG entry for

Medical Device Included Class Is

Sponsor

Medical Devices Pty Limited

Postal Address

PO Box 255,CONCORD, NSW, 2137

Australia

ARTG Start Date

1/08/2017

Product category

Medical Device Class Is

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

DTR Medical Ltd

17 Clarion Court Clarion Close

Swansea Enterprise Park, Swansea, SA6 8RF

United Kingdom

Products

1. Speculum, vaginal, single use

Product Type

Single Device Product

Effective date

1/08/2017

GMDN

37468 Speculum, vaginal, single use

Intended purpose

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.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 03.11.2017 at 09:32:19 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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