Urethral intravesical infusion tip

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

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Available from:
Juno Pharmaceuticals Pty Ltd
Class:
Class Is
Authorization status:
Included
Authorization number:
322020

Public Summary

Summary for ARTG Entry:

322020

Juno Pharmaceuticals Pty Ltd - Urethral intravesical infusion tip

ARTG entry for

Medical Device Included Class Is

Sponsor

Juno Pharmaceuticals Pty Ltd

Postal Address

Level 2 6 Bond Street,South Yarra, VIC, 3141

Australia

ARTG Start Date

20/08/2019

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

Dispomedicor Zrt

Furedi ut 98

, Debrecen, 4032

Hungary

Products

1. Urethral intravesical infusion tip

Product Type

Single Device Product

Effective date

20/08/2019

GMDN

64249 Urethral intravesical infusion tip

Intended purpose

The IALUADAPTER / MID-ii® urological syringe adapter is an item for a single use, tissue-friendly plastic

device that allows the drug solutions contained by the attached syringe to be delivered into the urinary

bladder.

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 06:28:30 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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