Pure Global

Inborn/inherited genetic disorder IVDs - ARTG 372316

Access comprehensive regulatory information for Inborn/inherited genetic disorder IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 372316 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Yourgene Health UK Limited in United Kingdom. The device registration started on August 06, 2021.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 372316
Class IIb
Inborn/inherited genetic disorder IVDs
ARTG ID: 372316
Good Name: Southern Cross Diagnostics Pty Ltd - Inborn/inherited genetic disorder IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

For the simultaneous in vitro qualitative detection of mutations associated with inborn/inherited genetic disorders.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
372316
Start Date
August 06, 2021
Effective Date
August 06, 2021
Manufacturer
Country
United Kingdom
Address
Skelton House Lloyd Street North Manchester Science Park, Manchester, M15 6SH