Biodrops Fresh Eyes Multi-Dose Bottle - Lubricant, eye

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

Buy It Now

Available from:
Bausch & Lomb Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
323790

Public Summary

Summary for ARTG Entry:

323790

Bausch & Lomb Australia Pty Ltd - Biodrops Fresh Eyes Multi-Dose Bottle - Lubricant, eye

ARTG entry for

Medical Device Included Class III

Sponsor

Bausch & Lomb Australia Pty Ltd

Postal Address

PO Box 292,Chatswood, NSW, 2057

Australia

ARTG Start Date

18/09/2019

Product category

Medical Device Class III

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

Dr Gerhard Mann Chem-Pharm Fabrik GmbH

Brunsbutteler Damm 165-173

BERLIN, , 13581

Germany

Products

1. Biodrops Fresh Eyes Multi-Dose Bottle - Lubricant, eye

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

44237 Lubricant, eye

Functional description

The product is ideal for instantly soothing and hydrating dry eyes caused by environmental factors. It

naturally refreshes and calms your dry eyes relieving symptoms of tired, irritated, even teary eyes. In the

innovative preservative free multi-dose system (PFMD), it provides all the benefits of a preservative free

solution within a multi drop bottle. It improves the comfort of your contact lenses noticeably, all day long.

Intended purpose

Eye lubricant and wetting and rewetting of both soft and hard contact lenses during wearing.

Variant information

Volume (mL) 10ml and 15ml bottle

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 08.11.2019 at 10:16:59 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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