Australia TGA ARTG record

Aqueous/vitreous humour replacement medium

Australia TGA ARTG Registered Device · Surgivision Pty Ltd · Atakan Dede - Miray Medikal · Class IIb · Started July 13, 2023

Good Name: Surgivision Pty Ltd - Aqueous/vitreous humour replacement medium

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 13, 2023
Effective Date: July 13, 2023

Sponsor

Name: Surgivision Pty Ltd

Manufacturer

Name: Atakan Dede - Miray Medikal
Country: Turkey
Address: Cali Mah 14 (410) Sok No: 14/B Nilufer, Bursa

Intended purpose

Serves as a volume substitute for aqueous humor during intraocular operations, such as extraction and insertion of an intraocular lens. Maintains the depth of the anterior chamber during surgery and reduces the danger of traumatization of the corneal endothelium, the iris and ciliary body by direct contact with surgical instruments. At the end of surgery, must be removed completely using a suitable irrigation/aspiration device.

About this record

Access comprehensive regulatory information for Aqueous/vitreous humour replacement medium in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Surgivision Pty Ltd, manufactured by Atakan Dede - Miray Medikal in Turkey. The device registration started on July 13, 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.