Pure Global

Flexi-Air - Foam bed mattress

Access comprehensive regulatory information for Flexi-Air - Foam bed mattress in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Apex Medical Corp in Taiwan. The device registration started on February 25, 2021.

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 I
Class I
Flexi-Air - Foam bed mattress
Australia TGA ARTG Registered Device
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Flexi-Air - Foam bed mattress
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Intended Purpose

This device is a hybrid mattress replacement system that combines foam with air for effective pressure redistribution and increased levels of comfort whilst providing extra support to help prevent the patient from bottoming-out, and reduce the risk of them acquiring pressure damage.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
February 25, 2021
Effective Date
February 25, 2021
Manufacturer
Country
Taiwan
Address
No 9 Min Sheng St Tu-cheng, New Taipei City, 23679