Dental delivery system, portable

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

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Available from:
P Raniga Dental Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
293620

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Public Summary

Summary for ARTG Entry:

293620

P Raniga Dental Pty Ltd - Dental delivery system, portable

ARTG entry for

Medical Device Included Class IIa

Sponsor

P Raniga Dental Pty Ltd

Postal Address

Letter Box 62 Victoria Point Shopping Centre,Victoria Point, QLD, 4165

Australia

ARTG Start Date

7/09/2017

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

Zhengzhou Huaer Electro-Optics Technology

Co Ltd

No 79 Zhenghua Road

Zhengzhou City, Henan Province, 450000

China

Products

1. Dental delivery system, portable

Product Type

Single Device Product

Effective date

7/09/2017

GMDN

60930 Dental delivery system, portable

Intended purpose

mobile dental unit including a compressor, high speed and slow speed handpieces, slow speed suction

and curing light. This is to do basic treatment patients who are immobile.

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 01.12.2017 at 06:35:05 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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