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Sleep assessment device - ARTG 426990

Access comprehensive regulatory information for Sleep assessment device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 426990 and sponsored by Sefam Medical Pty Ltd, manufactured by SOMNOmedics GmbH in Germany. The device registration started on October 26, 2023.

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 426990
Class IIa
Sleep assessment device
ARTG ID: 426990
Good Name: Sefam Medical Pty Ltd - Sleep assessment device
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Pricing
Intended Purpose

Device for recording, displaying, monitoring, printing, and storage of biophysical parameters. It is used for polygraphy, polysomnography and EEG recordings to assist in the diagnosis of sleep disorders, e.g. obstructive sleep apnoea syndrome

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
426990
Start Date
October 26, 2023
Effective Date
October 26, 2023
Manufacturer
Country
Germany
Address
Am Sonnenstuhl 63, Randersacker, Deutschland, 97236