Single-patient physiologic monitoring system

Public Summary

Summary for ARTG Entry:

322628

Quintessa Holdings Pty Ltd - Single-patient physiologic monitoring system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Quintessa Holdings Pty Ltd

Postal Address

Po Box 535,Heathmont, VIC, 3135

Australia

ARTG Start Date

3/09/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Biovotion AG

Kreuzstrasse 2

, Zurich, 8008

Switzerland

Products

1. Single-patient physiologic monitoring system

Product Type

Single Device Product

Effective date

3/09/2019

GMDN

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

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written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

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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