Australia TGA ARTG record

Spirometer, diagnostic

Australia TGA ARTG Registered Device · Genesis Biotech Pty Ltd · Contec Medical Systems Co Ltd · Class IIa · Started September 02, 2021

Good Name: Genesis Biotech Pty Ltd - Spirometer, diagnostic

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: September 02, 2021
Effective Date: September 02, 2021

Sponsor

Name: Genesis Biotech Pty Ltd

Manufacturer

Name: Contec Medical Systems Co Ltd
Country: China
Address: No 112 Qinhuang West Street Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004

Intended purpose

The SPIROMETER is a hand-held medical device for checking lung conditions, adopts the infrared signal acquisition mode for measuring items related to FVC, applicable for use in hospitals, clinics, and for routine test.

About this record

Access comprehensive regulatory information for Spirometer, diagnostic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Genesis Biotech Pty Ltd, manufactured by Contec Medical Systems Co Ltd in China. The device registration started on September 02, 2021.

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.