Colposcope

Main information

  • Trade name:
  • Colposcope
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Colposcope
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220614
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220614

10 Seas Consulting Pty Ltd T/a Videra Surgical & Diagnostics - Colposcope

ARTG entry for

Medical Device Included Class IIa

Sponsor

10 Seas Consulting Pty Ltd T/a Videra Surgical & Diagnostics

Postal Address

PO Box 371,The Junction, NSW, 2291

Australia

ARTG Start Date

28/02/2014

Product category

Medical Device Class IIa

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

Zilico Ltd

The MedTECH Centre Rutherford House

Pencroft Way Manchester Science Park

Manchester, , M15 6SZ

Products

1. Colposcope

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

10960 Colposcope

Intended purpose

The ZedScan is intended to be used as an adjunct to colposcopy in women suspected of having cervical

neoplasia and will improve the accuracy of colposcopy for the detection of High-Grade Cervical

Intraepithelial Neoplasia (HG-CIN; CIN2+).

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 02.12.2017 at 04:24:47 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