Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Atris Pty Ltd - Amplifier, physiological signal
ARTG entry for
Medical Device Included Class IIa
Atris Pty Ltd
19 Duchess Avenue,RODD POINT, NSW, 2046
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.
Voronin str 5
Ivanovo, , 153032
1. Amplifier, physiological signal
Medical device system
32521 Amplifier, physiological signal
Amplifier system designed for use in the recording of routine EEG overnight sleep/EEG (PSG,
Polysomnography)and other neurophysiological monitoring application
No Specific Conditions included on Record
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Produced at 03.11.2017 at 07:07:01 AEDT
This is not an ARTG Certificate document.
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