Nappy

Main information

  • Trade name:
  • Nappy, adult
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Nappy, adult
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221840
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221840

Endotherapeutics Pty Ltd - Nappy, adult

ARTG entry for

Medical Device Included Class 1

Sponsor

Endotherapeutics Pty Ltd

Postal Address

PO Box 673,EPPING, NSW, 1710

Australia

ARTG Start Date

1/04/2014

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

Europrosan SpA

Via Tonale 157

Marnate, Varese, 21050

Italy

Products

1. Nappy, adult

Product Type

Single Device Product

Effective date

1/04/2014

GMDN

11239 Nappy, adult

Intended purpose

A disposable absorbent device like normal under-wear designed for moderate to heavy incontinence.

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

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Produced at 09.11.2017 at 11:37:53 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