Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Spectacom Pty Ltd - 32816 Frame, spectacle - Frame, spectacle
ARTG entry for
Medical Device Included Class 1
Spectacom Pty Ltd
Shop 2 Pelican Waters S/C Pelican Waters Blvd,PELICAN WATERS, QLD, 4551
ARTG Start Date
Medical Device Class 1
- 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.
Universe Optical MFG Co Ltd
4F Fanhua Mansion No 116 Dingmaoqiao
Road Zhenjiang Jiangsu
1. 32816 Frame, spectacle - Frame, spectacle
Medical device system
32816 Frame, spectacle
GMDN 32816 Frame, spectacle. To hold prescription or protective spectacle lenses in front of the eyes.
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.
Page 1 of
Produced at 03.11.2017 at 06:10:29 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