Pure Global

Clinical chemistry substrate IVDs - ARTG 471425

Access comprehensive regulatory information for Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 471425 and sponsored by Plus Medical Pty Ltd, manufactured by Sejoy Biomedical Co Ltd in China. The device registration started on December 02, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 471425
Class IIb
Clinical chemistry substrate IVDs
ARTG ID: 471425
Good Name: Plus Medical Pty Ltd - Clinical chemistry substrate IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Test strips designed to measure blood glucose in blood when used in combination with a dedicated blood glucose meter by people with diabetes or their health care professionals. The analytical quality of the blood glucose result is monitored through the use of purpose designed quality control solutions. The blood glucose meter, its test strip and controls are commonly referred to as a "System".

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
471425
Start Date
December 02, 2024
Effective Date
December 02, 2024
Manufacturer
Country
China
Address
Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100