Summary for ARTG Entry:
Device Technologies Australia Pty Ltd - Defibrillator/pacemaker
ARTG entry for
Medical Device Included Class IIb
Device Technologies Australia Pty Ltd
Locked Bag 521,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class IIb
- 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.
CU Medical Systems Inc
130-1 Donghwagongdan-ro Munmak-eup
Korea - Republic of
Medical device system
17882 Physiologic-monitoring defibrillation system
A defibrillator system intended for use on patients that are exhibiting the symptoms of sudden cardiac
arrest by applying an electric shock to resuscitate the patient, correct arrhythmias or temporarily pace.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:18:54 AEDT
This is not an ARTG Certificate document.
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