Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
ACRA Regulatory Services Pty Ltd - Sterilization packaging, single-use
ARTG entry for
Medical Device Included Class 1
ACRA Regulatory Services Pty Ltd
7/84 Poincina Avenue,Tewantin, QLD, 4565
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.
Rups Packaging Industry
A-196 Sector 83
, Noida, 201 305
1. Sterilization packaging, single-use
Single Device Product
13735 Sterilization packaging, single-use
Sterilization medical grade pouches and paper rolls intended to be used to enclose another medical device
in a single pouch configuration to allow sterilization of the enclosed medical device and also to maintain
sterility of the device until the packaging is opened for use of the device
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Produced at 08.11.2019 at 10:20:37 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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