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CPAP/BiPAP face mask, reusable

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.

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TGA ARTG Official Data
Class IIa
Class IIa
CPAP/BiPAP face mask, reusable
Australia TGA ARTG Registered Device
Good Name: Sefam Medical Pty Ltd - CPAP/BiPAP face mask, reusable
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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)

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
Manufacturer
Country
Taiwan
Address
No 312 Jhongshan Rd Shengang District, Taichung City, Taiwan