Transdermal needle roller, reusable

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

Buy It Now

Available from:
Amazing Oils Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
324150

Public Summary

Summary for ARTG Entry:

324150

Amazing Oils Pty Ltd - Transdermal needle roller, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Amazing Oils Pty Ltd

Postal Address

45 Quiet Valley Crescent,BUDERIM, QLD, 4556

Australia

ARTG Start Date

27/09/2019

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

Beijing Sea Heart International Science and

Technology

Rm 812 No 3 Building Jingtai Independent City

Nanqiao Shiba Lidian

Chaoyang District, Beijing,

China

Products

1. Transdermal needle roller, reusable

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

37474 Transdermal needle roller, reusable

Intended purpose

A device to be rolled over the skin to create high-density minute skin punctures to stimulate tissue

regeneration and improve skin appearance. It combines LED light treatment to help skin rejuvenation. This

skin treatment technique is used for skin rejuvenation, to treat stretch marks, acne scarring,

hyperpigmentation, wrinkles, and for hair loss therapy.

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 03:36:18 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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