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Clinical chemistry hormone IVDs

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 3P Pty Ltd, manufactured by Nantong Egens Biotechnology Co Ltd in China. The device registration started on January 12, 2018.

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
Class IIa
Clinical chemistry hormone IVDs
Australia TGA ARTG Registered Device
Good Name: 3P Pty Ltd - Clinical chemistry hormone IVDs
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Intended Purpose

An IVD intended to be used for the rapid qualitative determination of human chorionic gonadotropin (hCG) in human urine samples, as an aid in the early detection of pregnancy; and an IVD intended to be used for the rapid qualitative determination of luteinizing hormone (LH) inn human urine samples as an aid in the prediction of ovulation.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
January 12, 2018
Effective Date
June 17, 2024
Sponsor
Manufacturer
Country
China
Address
Building 15 Building 12 (West) No 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone, Nantong, 226010