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Home BPAP Unit - ARTG 399062

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 registered under ARTG number 399062 and 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.

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Class IIa
ARTG 399062
Class IIa
Home BPAP Unit
ARTG ID: 399062
Good Name: Sefam Medical Pty Ltd - Home BPAP unit
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399062
Start Date
November 09, 2022
Effective Date
November 09, 2022
Manufacturer
Name
SEFAM
Country
France
Address
144 avenue Charles de Gaulle Neuilly, Sur Seine, 92200