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Clinical chemistry biological screening IVDs - ARTG 286937

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 286937 and sponsored by We Test Bio Pty Ltd, manufactured by YD Diagnostics Corp in South Korea. The device registration started on March 20, 2017.

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 IIa
ARTG 286937
Class IIa
Clinical chemistry biological screening IVDs
ARTG ID: 286937
Good Name: We Test Bio Pty Ltd - Clinical chemistry biological screening IVDs
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Intended Purpose

Urine self-test strips to detect general urine chemistry analytes ( pH, protein, glucose and specific gravity) and other parameters for use in general health and well-being.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
286937
Start Date
March 20, 2017
Effective Date
January 09, 2024
Manufacturer
Country
South Korea
Address
76 Seori-ro Idong-myeon Cheoin-gu, Yongin-si, Gyeonggi-do, 17127