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Clinical chemistry substrate IVDs - ARTG 467766

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 467766 and sponsored by Plus Medical Pty Ltd, manufactured by Sejoy Biomedical Co Ltd in China. The device registration started on November 08, 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 IIb
ARTG 467766
Class IIb
Clinical chemistry substrate IVDs
ARTG ID: 467766
Good Name: Plus Medical Pty Ltd - Clinical chemistry substrate IVDs
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Intended Purpose

It is intended to be used together with Secure Plus BS-602 Blood Glucose Test Strips for checking if the Secure Plus Blood Glucose Monitoring System operates correctly and works properly to ensure accurate results measured.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
467766
Start Date
November 08, 2024
Effective Date
November 08, 2024
Manufacturer
Country
China
Address
Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100