Australia TGA ARTG record

CPAP/BiPAP face mask, reusable

Australia TGA ARTG Registered Device · Sefam Medical Pty Ltd · Hsiner Co Ltd · Class IIa · Started December 02, 2022

Good Name: Sefam Medical Pty Ltd - CPAP/BiPAP face mask, reusable

Device classification

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

Registration information

Start Date: December 02, 2022
Effective Date: December 02, 2022

Sponsor

Name: Sefam Medical Pty Ltd

Manufacturer

Name: Hsiner Co Ltd
Country: Taiwan
Address: No 312 Jhongshan Rd Shengang District, Taichung City, Taiwan

Intended purpose

A reusable facial mask designed for non invasive ventilation via the use of a barometric device delivering continuous positive airway pressure (CPAP) or bi-level pressure (BiPAP)

About this record

Access comprehensive regulatory information for CPAP/BiPAP face mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Sefam Medical Pty Ltd, manufactured by Hsiner Co Ltd in Taiwan. The device registration started on December 02, 2022.

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.