ActiveCare - Alarm, emergency assistance

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
NPA Pty Ltd T/a Cura1
Class:
Class 1
Authorization status:
Included
Authorization number:
322998

Public Summary

Summary for ARTG Entry:

322998

NPA Pty Ltd T/a Cura1 - ActiveCare - Alarm, emergency assistance

ARTG entry for

Medical Device Included Class 1

Sponsor

NPA Pty Ltd T/a Cura1

Postal Address

10 Gray Street,KILKENNY, SA, 5009

Australia

ARTG Start Date

11/09/2019

Product category

Medical Device Class 1

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

NPA Pty Ltd T/a Cura1

10 Gray Street

KILKENNY, SA, 5009

Australia

Products

1. ActiveCare - Alarm, emergency assistance

Product Type

Medical device system

Effective date

11/09/2019

GMDN

30087 Alarm, emergency assistance

Intended purpose

To alert staff and caregivers when a person in their care requires assistance or attention:

The system comprises of:

4024 Wireless Pager Kit

2721 iBeam

2723 Ezystand

4000 Door Monitor

4001 Wristband Transmitter

4002 Reset Button

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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 04:32:28 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.

Visit www.tga.gov.au for contact information

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