Blanket,

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

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Available from:
SLEEP IN HARMONY
Class:
Class 1
Authorization status:
Included
Authorization number:
322573

Public Summary

Summary for ARTG Entry:

322573

SLEEP IN HARMONY - Blanket, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

SLEEP IN HARMONY

Postal Address

PO BOX 244,Gisbourne, VIC, 3437

Australia

ARTG Start Date

2/09/2019

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

Chengdu Yixi Textile Co Ltd

No2108 21st Floor Unit 1 Building 8 No1700

North Section of Tianfu Avenue

Chengdu High-Tech Zone

, China,

China

Products

1. Blanket, <specify>

Product Type

Single Device Product

Effective date

2/09/2019

GMDN

40488 Blanket, <specify>

Intended purpose

The blankets of various sizes and weight, based on consumers individuals needs is to provide comfort,

calming, and relaxation. The Blanket's are to assist purchasers with evenly distributed pressure, providing

sensory stimulation against the body, creating a calming effect. This is to support those experiencing

anxiety, restlessness, unease, irritability, sleeplessness or just for comfort. Due to the weight of the

blankets, they should be stored appropriately to avoid tripping or falling over it.

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 05:27:23 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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