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OphteisBio 1.8% - Aqueous/vitreous humour replacement medium

Australia TGA ARTG Registered Device · Kevin Grundy (IBD) Pty Ltd · Rayner Intraocular Lenses Ltd · Class III · Started November 14, 2023

Good Name: Kevin Grundy (IBD) Pty Ltd - OphteisBio 1.8% - Aqueous/vitreous humour replacement medium

Device classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration information
Start Date
November 14, 2023
Effective Date
November 14, 2023
Sponsor
Manufacturer
Country
United Kingdom
Address
The Ridley Innovation Centre 10 Dominion Way, Worthing, West Sussex, BN14 8AQ
Intended purpose

Indicated for use in intraocular surgery of the anterior segment, including cataract extraction and intraocular lens implantation. The viscoelastic properties of OphteisBio 1.8% allow lubrication, support and protection of ocular tissues during ophthalmic surgery. Maintains the depth of the anterior chamber during surgery, allows for efficient manipulation with reduced trauma to the corneal endothelium and other surrounding tissues.

About this record

Access comprehensive regulatory information for OphteisBio 1.8% - Aqueous/vitreous humour replacement medium in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Kevin Grundy (IBD) Pty Ltd, manufactured by Rayner Intraocular Lenses Ltd in United Kingdom. The device registration started on November 14, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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