Cerebrospinal fluid pressure regulation system sensor/tubing set

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)

01-11-2019

Saadav alates:
Precise Medical Supplies Pty Ltd
Klass:
Class Is
Volitamisolek:
Included
Müügiloa number:
324141

Public Summary

Summary for ARTG Entry:

324141

Precise Medical Supplies Pty Ltd - Cerebrospinal fluid pressure regulation system sensor/tubing set

ARTG entry for

Medical Device Included Class Is

Sponsor

Precise Medical Supplies Pty Ltd

Postal Address

PO Box 421,Paddington, NSW, 2021

Australia

ARTG Start Date

27/09/2019

Product category

Medical Device Class Is

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

Moller Medical GmbH

Wasserkuppenstrasse 29-31

Fulda, , 36043

Germany

Products

1. Cerebrospinal fluid pressure regulation system sensor/tubing set

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

59960 Cerebrospinal fluid pressure regulation system sensor/tubing set

Intended purpose

A drainage bag for the collection of liquor fluid. The bag is intended as an exchange /replacement item for

a drainage bag that is part of a cerebrospinal fluid pressure regulation system sensor/tubing set.

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 03:38:27 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

Otsige selle tootega seotud teateid

Jagage seda teavet