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Irrigation fluid, medical/surgical procedure - ARTG 468271

Access comprehensive regulatory information for Irrigation fluid, medical/surgical procedure in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 468271 and sponsored by AMO Australia Pty Ltd, manufactured by Serumwerk Bernburg AG in Germany. The device registration started on November 12, 2024.

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 IIa
ARTG 468271
Class IIa
Irrigation fluid, medical/surgical procedure
ARTG ID: 468271
Good Name: AMO Australia Pty Ltd - Irrigation fluid, medical/surgical procedure
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Intended Purpose

The device is intended for the irrigation of the anterior chamber during cataract surgery and for other intraocular or extraocular procedures, such as therapeutic or diagnostic measures, where irrigation or retention of moisture is required.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
468271
Start Date
November 12, 2024
Effective Date
November 12, 2024
Manufacturer
Country
Germany
Address
Hallesche Landstrasse 105b, Bernburg, 06406