Single-patient physiologic monitoring system

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

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זמין מ:
Quintessa Holdings Pty Ltd
Class IIa
מצב אישור:
מספר אישור:

Public Summary

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

Postal Address

Po Box 535,Heathmont, VIC, 3135


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Biovotion AG

Kreuzstrasse 2

, Zurich, 8008



1. Single-patient physiologic monitoring system

Product Type

Single Device Product

Effective date



33586 Single-patient physiologic monitoring system

Intended purpose

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 patient.

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.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

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Produced at 02.11.2019 at 05:17:01 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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