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Clinical chemistry hormone IVDs

Australia TGA ARTG Registered Device · Aceso Diagnostics Pty Ltd · Hangzhou Alltest Biotech Co Ltd · Class IIa · Started January 17, 2024

Good Name: Aceso Diagnostics Pty Ltd - Clinical chemistry hormone IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
Start Date
January 17, 2024
Effective Date
January 17, 2024
Sponsor
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou, 310018
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.

About this record

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 sponsored by Aceso Diagnostics Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on January 17, 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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