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Gown, isolation, single use - ARTG 371866

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 registered under ARTG number 371866 and sponsored by Pro-Tek Plastics Australia, manufactured by Crown Name (WH) United Co Ltd in China. The device registration started on July 29, 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
ARTG 371866
Class I
Gown, isolation, single use
ARTG ID: 371866
Good Name: Pro-Tek Plastics Australia - Gown, isolation, single use
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Intended Purpose

To provide protection for healthcare personnel/visitors and reduce the risk of contamination

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
371866
Start Date
July 29, 2021
Effective Date
July 29, 2021
Manufacturer
Country
China
Address
Changhang Building RM 1805 No 69 Yanjiang Avenue, Wuhan, Hubei, 430021