Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Nipro Australia Pty Ltd - Manual blood lancing device, single-use
ARTG entry for
Medical Device Included Class IIa
Nipro Australia Pty Ltd
Level 2 / 657 Pacific Highway St Leonards,Sydney, NSW, 2065
ARTG Start Date
Medical Device Class IIa
- 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.
Taidoc Technology Corporation
B1-7F No 127 Wugong 2nd Road Wugu Dist
New Taipei City, , 24888
Taiwan (Province of China)
1. Manual blood lancing device, single-use
Single Device Product
61578 Manual blood lancing device, single-use
The lancets are intended for single use only in the penetration of human skin to obtain whole blood
No Specific Conditions included on Record
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Produced at 03.11.2017 at 11:48:24 AEDT
This is not an ARTG Certificate document.
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