Australia TGA ARTG record

Clinical chemistry hormone IVDs

Australia TGA ARTG Registered Device · Schiffa Health Pty Ltd · Nantong Egens Biotechnology Co Ltd · Class IIa · Started July 05, 2017

Good Name: Schiffa Health Pty Ltd - Clinical chemistry hormone IVDs

Device classification

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

Registration information

Start Date: July 05, 2017
Effective Date: July 05, 2017

Sponsor

Name: Schiffa Health Pty Ltd

Manufacturer

Name: Nantong Egens Biotechnology Co Ltd
Country: China
Address: Block A No15 Building No1692 Xinghu Ave Nantong Economy & Tech Development Zone, 226010

Intended purpose

Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of Chorionic Gonadotropin (hCG) in urine samples to aid the early detection of pregnancy by professional users.

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 Schiffa Health Pty Ltd, manufactured by Nantong Egens Biotechnology Co Ltd in China. The device registration started on July 05, 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.