Pure Global

Mask, surgical, single use

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 sponsored by AF Group Holdings Pty Ltd, manufactured by Guangdong Kaidi Garments Co Ltd in China. The device registration started on April 15, 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
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: AF Group Holdings Pty Ltd - Mask, surgical, single use
Pure Global
DJ Fang

DJ Fang

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Pricing
Intended Purpose

Product is mainly used in protective anti-dust operation for prevention, nursing, general anti-dust, self-use, anti-virus, etc. It can be worn by all kinds of clinical personnel during non-invasive operation, covering the user's mouth, nose and jaw, and providing a barrier to prevent direct penetration of pathogenic microorganism, particulate matter, etc.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 15, 2020
Effective Date
April 15, 2020
Manufacturer
Country
China
Address
Shenxiyang Industrial Zone Fengshan Street Heping Town Chaoyang, Shantou, Guangdong