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Clinical chemistry hormone IVDs - ARTG 476445

Access comprehensive regulatory information for Clinical chemistry hormone IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 476445 and sponsored by Key Pharmaceuticals Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on January 22, 2025.

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 476445
Class IIa
Clinical chemistry hormone IVDs
ARTG ID: 476445
Good Name: Key Pharmaceuticals Pty Ltd - Clinical chemistry hormone IVDs
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DJ Fang

DJ Fang

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Intended Purpose

The HCG Pregnancy, LH ovulation and follicle stimulating hormone test devices are self testing rapid tests for women to use at home, using urine for the respective evaluations of pregnancy, ovulation and the onset of menopause.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
476445
Start Date
January 22, 2025
Effective Date
January 22, 2025
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou, 310018