Mirror

Main information

  • Trade name:
  • Mirror, ear/nose/throat
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mirror, ear/nose/throat
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216232
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216232

CoreMed Pty Ltd - Mirror, ear/nose/throat

ARTG entry for

Medical Device Included Class 1

Sponsor

CoreMed Pty Ltd

Postal Address

PO Box 565,BALMAIN, NSW, 2041

Australia

ARTG Start Date

20/10/2013

Product category

Medical Device Class 1

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

Spiggle & Theis Medizintechnik GmbH

Burghof 14

Overath, , 51491

Germany

Products

1. Mirror, ear/nose/throat

Product Type

Single Device Product

Effective date

20/10/2013

GMDN

33431 Mirror, ear/nose/throat

Intended purpose

An instrument with a surface sufficiently polished to reflect enough undiffused light to form a virtual image

of an object placed before it, for purposes of ear/nose/throat (ENT) examinations. This mirror is mounted

on a slender handle, as opposed to a headband.

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 10.11.2017 at 05:33:54 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

19-10-2018

Crate and Barrel Canada, Inc. recalls Josephine Floor Mirrors

Crate and Barrel Canada, Inc. recalls Josephine Floor Mirrors

The mirror's glass can separate from the wooden backing and fall, posing a laceration hazard.

Health Canada

14-8-2018

The Uttermost Company recalls Various Types of Mirrors, Art and Wall Décor sold with Adjustable J-Hook Hanging Hardware

The Uttermost Company recalls Various Types of Mirrors, Art and Wall Décor sold with Adjustable J-Hook Hanging Hardware

The hanging hardware can break, causing mirrors and wall décor to fall from walls, posing an injury hazard to bystanders.

Health Canada

There are no news related to this product.