Pure Global

Sleep disorder interpretive software, professional-use

Access comprehensive regulatory information for Sleep disorder interpretive software, professional-use 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 10, 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
Class IIa
Sleep disorder interpretive software, professional-use
Australia TGA ARTG Registered Device
Good Name: Sefam Medical Pty Ltd - Sleep disorder interpretive software, professional-use
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Intended Purpose

Data management software intended for use by healthcare professionals with CPAP/BPAP devices. The software allows the setting of CPAP/BPAP device parameters, and to monitor and transmit the patient's medical parameters to healthcare professionals.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 10, 2022
Effective Date
November 10, 2022
Manufacturer
Name
SEFAM
Country
France
Address
144 avenue Charles de Gaulle Neuilly, Sur Seine, 92200