Australia TGA ARTG record

Heel protector

Australia TGA ARTG Registered Device · Intermed Medical Pty Ltd · Shanghai Darco Medical Products Co Ltd · Class I · Started April 22, 2020

Good Name: Intermed Medical Pty Ltd - Heel protector

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 22, 2020
Effective Date: April 22, 2020

Sponsor

Name: Intermed Medical Pty Ltd

Manufacturer

Name: Shanghai Darco Medical Products Co Ltd
Country: China
Address: Building 1-3 No 128 Lane 3458 Humin Road Zhuanqiao Town, Minhang District, Shanghai, 201108

Intended purpose

Intended to be used to distribute pressure on the heel in high risk patients that have sores and ulceration. Suitable for patients with a Braden Score of 14 or less, no palpable pedal pulse, susceptible to pressure paraplegia, prolonged immobility

About this record

Access comprehensive regulatory information for Heel protector in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Intermed Medical Pty Ltd, manufactured by Shanghai Darco Medical Products Co Ltd in China. The device registration started on April 22, 2020.

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.