Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Instrument/analyser IVDs
ARTG entry for
Medical Device Included - IVD Class 1
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
Quintron Instrument Company
2208 S 38th Street
Milwaukee, Wisconsin, 53215
United States Of America
1. Instrument/analyser IVDs
CT943 Instrument/analyser IVDs
Intended use of the BreathTracker analyzer is to aid in the diagnosis of various gastrointestinal conditions.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:46:35 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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