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Helicobacter IVDs - ARTG 404096

Access comprehensive regulatory information for Helicobacter IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 404096 and sponsored by Integrated Sciences Pty Ltd, manufactured by Seegene Inc in South Korea. The device registration started on January 31, 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 404096
Class IIb
Helicobacter IVDs
ARTG ID: 404096
Good Name: Integrated Sciences Pty Ltd - Helicobacter IVDs
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Intended Purpose

Assay for the qualitative detection of H. pylori and mutations responsible for clarithromycin resistance of H. pylori

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
404096
Start Date
January 31, 2023
Effective Date
January 31, 2023
Manufacturer
Country
South Korea
Address
Taewon Bldg 91, Ogeum-ro Songpa-gu, Seoul, 05548