Australia TGA ARTG record

Ophteis FR Pro - 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 - Ophteis FR Pro - 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

Name: Kevin Grundy (IBD) Pty Ltd

Manufacturer

Name: Rayner Intraocular Lenses Ltd
Country: United Kingdom
Address: The Ridley Innovation Centre 10 Dominion Way, Worthing, West Sussex, BN14 8AQ

Intended purpose

Ophteis FR Pro is an injectable solution for use as a surgical aid in surgery of the anterior and posterior segments of the eye: • Cataract surgery with or without intraocular lens implantation • Glaucoma surgery

About this record

Access comprehensive regulatory information for Ophteis FR Pro - 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.