ARTG 471425Clinical chemistry substrate IVDs
ARTG ID: 471425 · Plus Medical Pty Ltd · Sejoy Biomedical Co Ltd · Class IIb · Started December 02, 2024
Good Name: Plus Medical Pty Ltd - Clinical chemistry substrate IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 471425
- Start Date
- December 02, 2024
- Effective Date
- December 02, 2024
- Country
- China
- Address
- Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100
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".
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.