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Home CPAP unit - ARTG 304987

Access comprehensive regulatory information for Home CPAP unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 304987 and sponsored by Sefam Medical Pty Ltd, manufactured by SEFAM in France. The device registration started on June 22, 2018.

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 304987
Class IIa
Home CPAP unit
ARTG ID: 304987
Good Name: Sefam Medical Pty Ltd - Home CPAP unit
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Intended Purpose

This device is intended to treat patients suffering from Obstructive Sleep Apnea Syndrome (OSA) in patients over 30 kg

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
304987
Start Date
June 22, 2018
Effective Date
June 22, 2018
Manufacturer
Name
SEFAM
Country
France
Address
144 avenue Charles de Gaulle Neuilly, Sur Seine, 92200