Nasopharyngeal swab

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

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Available from:
Keyport Pty Ltd T/A SANICAL
Class:
Class 1
Authorization status:
Included
Authorization number:
339890

Public Summary

Summary for ARTG Entry:

339890

Keyport Pty Ltd T/A SANICAL - Nasopharyngeal swab

ARTG entry for

Medical Device Included Class 1

Sponsor

Keyport Pty Ltd T/A SANICAL

Postal Address

22A Linlithgow Road, Toorak, VIC, 3142

Australia

ARTG Start Date

21/07/2020

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

Sunwing Industries Limited

Bldg 2 Win-world Originality Industrial Park No

6 Guang Hua Dong Jie

, NanJing, 210007

China

Products

1 . Nasopharyngeal swab

Product Type

Single Device Product

Effective Date

21/07/2020

GMDN

57940 Nasopharyngeal swab

Intended Purpose

Intended to be used for the collection and transportation of biological samples for subsequent microbiological analysis

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 22.07.2020 at 08:07:43 AEST

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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