Non-woven gauze pad, sterile

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)

08-11-2019

Dostopno od:
Dats Pty Ltd
Razred:
Class Is
Status dovoljenje:
Included
Številka dovoljenja:
323469

Public Summary

Summary for ARTG Entry:

323469

Dats Pty Ltd - Non-woven gauze pad, sterile

ARTG entry for

Medical Device Included Class Is

Sponsor

Dats Pty Ltd

Postal Address

PO Box 6798,Wetherill Park, NSW, 2164

Australia

ARTG Start Date

16/09/2019

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

Zhejiang Changdi Medical Co Ltd

No 208 Guangfu West Street Jiangbei Light

Industry Zone

Dongyang City, Zhejiang Province, 322100

China

Products

1. Non-woven gauze pad, sterile

Product Type

Single Device Product

Effective date

16/09/2019

GMDN

48131 Non-woven gauze pad, sterile

Intended purpose

Sterile and non-adherent single use gauze pads used to clean and/or cover minor wounds or abrasions

and absorb their exudates.

Specific Conditions

© 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 08.11.2019 at 10:37:43 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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