Vitreous humour replacement medium rinsing solution.

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

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Available from:
IQ Medical
Class IIa
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


IQ Medical - Vitreous humour replacement medium rinsing solution.

ARTG entry for

Medical Device Included Class IIa


IQ Medical

Postal Address

2 / 86 Mary Street,UNLEY, SA, 5061


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.




Fluoron GmbH

Magirus-Deutz-Str 10

, Ulm, 89077



1. Vitreous humour replacement medium rinsing solution.

Product Type

Single Device Product

Effective date



64238 Vitreous humour replacement medium rinsing solution.

Intended purpose

A liquid substance (semifluorinated alkane)intended for intraoperative use as a transient medium [rinsing

solution] to remove vitreous humour replacement medium residues (e.g., silicone oil residues) from the

vitreous chamber after long-term retinal tamponade; it may in addition be intended to be used as a

cleaning medium for an intraocular lens [IOL] following tamponade. It is intended to be injected into the

interior of the eye, and may be supplied in a prefilled syringe or other container. This is a single-use device

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 03:11:54 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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