Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Health Teams Pty Ltd · Contec Medical Systems Co Ltd · Class I · Started March 25, 2024

Good Name: Health Teams Pty Ltd - Instrument/analyser IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: March 25, 2024
Effective Date: March 27, 2024

Sponsor

Name: Health Teams Pty Ltd

Manufacturer

Name: Contec Medical Systems Co Ltd
Country: China
Address: No 112 Qinhuang West Street Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004

Intended purpose

This semi-automatic device is designed for clinical urine testing, offering high precision and intelligence. It is developed based on cutting-edge optics, electronics, and computer science technologies. When used with specialised test strips, it allows for semi-quantitative analysis of various urine parameters, including pH, nitrite, glucose, protein, occult blood, ketone bodies, bilirubin, urobilinogen, specific gravity, leukocytes, vitamin C, microalbumin, creatinine, and urinary calcium. It is ideal for use in hospitals, community health centres, clinics, and disease prevention stations, and should be operated by professionals with clinical experience.

About this record

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Health Teams Pty Ltd, manufactured by Contec Medical Systems Co Ltd in China. The device registration started on March 25, 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.