Surgical procedure kit, dental, non-medicated, single-use

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

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Available from:
Plus Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
321415

Public Summary

Summary for ARTG Entry:

321415

Plus Medical Pty Ltd - Surgical procedure kit, dental, non-medicated, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Plus Medical Pty Ltd

Postal Address

1A Coronation Avenue,Kings Park, NSW, 2148

Australia

ARTG Start Date

7/08/2019

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

Shanghai Everpure Medical Plastic Co Ltd

No 2418 Tingfeng Rd Xinnong Town

Jinshan District, Shanghai, 201503

China

Products

1. Surgical procedure kit, dental, non-medicated, single-use

Product Type

Procedure Pack

Effective date

7/08/2019

GMDN

45148 Surgical procedure kit, dental, non-medicated, single-use

Intended purpose

A collection of various instruments for use in dental surgical procedures.

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 02.11.2019 at 07:43:17 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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