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Mask, surgical, single use - ARTG 378570

Access comprehensive regulatory information for Mask, surgical, 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 378570 and sponsored by VITRYL AUS PTY LTD, manufactured by Guangdong Kaidi Garments Co Ltd in China. The device registration started on November 23, 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 378570
Class I
Mask, surgical, single use
ARTG ID: 378570
Good Name: VITRYL AUS PTY LTD - Mask, surgical, single use
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DJ Fang

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Intended Purpose

This is a disposable device in the form of a mask that is intended to be placed over the nose and mouth by medical/dental personnel to prevent the transmission of airborne organisms while surgery, examination and other procedures are being performed to prevent cross contamination.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
378570
Start Date
November 23, 2021
Effective Date
November 23, 2021
Manufacturer
Country
China
Address
Shenxiyang Industrial Zone Fengshan Street Heping Town Chaoyang, Shantou, Guangdong