Australia - englanti - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Quintessa Holdings Pty Ltd - Single-patient physiologic monitoring system
ARTG entry for
Medical Device Included Class IIa
Quintessa Holdings Pty Ltd
Po Box 535,Heathmont, VIC, 3135
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.
, Zurich, 8008
1. Single-patient physiologic monitoring system
Single Device Product
33586 Single-patient physiologic monitoring system
Everion CD / Everion MD is a wearable device which monitors the vital signs of a patient in either a clinical
setting or in a home care setting. This data can be used by the physician to determine the health status of
The Everion CD / Everion MD is not intended for continuous monitoring of life-threatening situations. It
does not warn the patient or physician in case of acute, life-threatening health situations.
The Everion is used by an individual patient. The patient shall be at least 18 years old and capable to
handle the Everion CD / Everion MD by him- or herself.
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Produced at 02.11.2019 at 05:17:01 AEDT
This is not an ARTG Certificate document.
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