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Humidifier, heated

Access comprehensive regulatory information for Humidifier, heated 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 December 22, 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
Humidifier, heated
Australia TGA ARTG Registered Device
Good Name: Sefam Medical Pty Ltd - Humidifier, heated
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Intended Purpose

The device is designed to warm and humidify gases delivered to patients requiring positive pressure breathing assistance via a face mask.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 22, 2022
Effective Date
December 22, 2022
Manufacturer
Name
SEFAM
Country
France
Address
144 avenue Charles de Gaulle Neuilly, Sur Seine, 92200