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Alternating-pressure bed mattress overlay system - ARTG 236070

Access comprehensive regulatory information for Alternating-pressure bed mattress overlay system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 236070 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Wellell Inc in Taiwan. The device registration started on April 10, 2015.

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
ARTG 236070
Class IIa
Alternating-pressure bed mattress overlay system
ARTG ID: 236070
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Alternating-pressure bed mattress overlay system
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Intended Purpose

This device is intended to help and reduce the incidence of pressure ulcers while optimizing patient comfort; long term home care of patients suffering from pressure ulcers; pain management as prescribed by a physician.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
236070
Start Date
April 10, 2015
Effective Date
April 10, 2015
Manufacturer
Country
Taiwan
Address
No 9 Min Sheng St, Tu-Cheng, New Taipei City