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Gown, isolation, single use

Access comprehensive regulatory information for Gown, isolation, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Molnlycke Health Care Pty Ltd, manufactured by Cobes Health Care (Hefei) Co Ltd in China. The device registration started on July 24, 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.

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Class I
Class I
Gown, isolation, single use
Australia TGA ARTG Registered Device
Good Name: Molnlycke Health Care Pty Ltd - Gown, isolation, single use
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Intended Purpose

A multipurpose garment, worn by healthcare providers or visitors to isolate them from the patient. The isolation gown helps protect the patient, e.g. burns patients, from the transfer of infectious agents carried by the healthcare provider or visitor; or it can protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a disposable garment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 24, 2020
Effective Date
July 24, 2020
Manufacturer
Country
China
Address
No 39 Liaoyuan Road Economic Development Zone Feidong Country, Hefei, Anhui Province, 231600