Australia TGA ARTG record

Home BPAP Unit

Australia TGA ARTG Registered Device · Sefam Medical Pty Ltd · SEFAM · Class IIa · Started November 09, 2022

Good Name: Sefam Medical Pty Ltd - Home BPAP unit

Device classification

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

Registration information

Start Date: November 09, 2022
Effective Date: November 09, 2022

Sponsor

Name: Sefam Medical Pty Ltd

Manufacturer

Name: SEFAM
Country: France
Address: 144 avenue Charles de Gaulle Neuilly, Sur Seine, 92200

Intended purpose

BPAP devices intended for use as Non-Invasive Ventilation in patients :

About this record

Access comprehensive regulatory information for Home BPAP Unit 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 SEFAM in France. The device registration started on November 09, 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.