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Aqueous/vitreous humour replacement medium - ARTG 413441

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 registered under ARTG number 413441 and 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.

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Class IIb
ARTG 413441
Class IIb
Aqueous/vitreous humour replacement medium
ARTG ID: 413441
Good Name: Surgivision Pty Ltd - Aqueous/vitreous humour replacement medium
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
413441
Start Date
July 13, 2023
Effective Date
July 13, 2023
Manufacturer
Country
Turkey
Address
Cali Mah 14 (410) Sok No: 14/B Nilufer, Bursa