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Gown, examination, single use - ARTG 337639

Access comprehensive regulatory information for Gown, examination, 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 337639 and sponsored by Palladium International Pty Ltd, manufactured by Cobes Industries Hefei Co Ltd in China. The device registration started on June 10, 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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TGA ARTG Official Data
Class I
ARTG 337639
Class I
Gown, examination, single use
ARTG ID: 337639
Good Name: Palladium International Pty Ltd - Gown, examination, single use
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DJ Fang

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Intended Purpose

L2 Non-Sterile Isolation Gown, Examination, Single Use; used during examination procedures. It meets Level 2 Standards for barrier performance. This is a disposable garment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
337639
Start Date
June 10, 2020
Effective Date
June 10, 2020
Manufacturer
Country
China
Address
No 39 Liaoyuan Road Xincheng Development Zone, Hefei, Anhui