Australia flagARTG 227774

Alternating-pressure bed mattress overlay system

ARTG ID: 227774 · Forte Healthcare Pty Ltd · Pe & Le Enterprise Ltd · Class I · Started September 10, 2014

Good Name: Forte Healthcare Pty Ltd - Alternating-pressure bed mattress overlay system

Device classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
227774
Start Date
September 10, 2014
Effective Date
September 10, 2014
Sponsor
Manufacturer
Country
Taiwan
Address
16-5 266 Sec 1 Wunhua 2nd Road, Linkou Township, Taipei Country, 24448
Intended purpose

An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

About this record

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 I is registered under ARTG number 227774 and sponsored by Forte Healthcare Pty Ltd, manufactured by Pe & Le Enterprise Ltd in Taiwan. The device registration started on September 10, 2014.

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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