Australia - inglese - Department of Health (Therapeutic Goods Administration)
01-11-2019
Public Summary
Summary for ARTG Entry:
321466
Australian Medical Systems Pty Ltd - Infrared-light vein locater
ARTG entry for
Medical Device Included Class 1
Sponsor
Australian Medical Systems Pty Ltd
Postal Address
PO Box 3471,ERINA, NSW, 2250
Australia
ARTG Start Date
8/08/2019
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
BLZ Technology (wuhan) Co Ltd
Room 2166 2176 Building E Cyberport
Dongxing Road
East Lake New Technology Development Zone
, Wuhan, 430074
China
Products
1. Infrared-light vein locater
Product Type
Single Device Product
Effective date
8/08/2019
GMDN
48040 Infrared-light vein locater
Intended purpose
A device used to illuminate a patient's veins.
Specific Conditions
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Public Summary
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Produced at 02.11.2019 at 07:36:31 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.
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