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Skin-cleaning wipe, non-sterile - ARTG 335190

Access comprehensive regulatory information for Skin-cleaning wipe, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 335190 and sponsored by Red Oak Medical Pty Ltd, manufactured by Guangzhou Baihua Company Limited in China. The device registration started on April 25, 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 335190
Class I
Skin-cleaning wipe, non-sterile
ARTG ID: 335190
Good Name: Red Oak Medical Pty Ltd- Skin-cleaning wipe, non-sterile
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Intended Purpose

A non-sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
335190
Start Date
April 25, 2020
Effective Date
April 25, 2020
Manufacturer
Country
China
Address
Floor 1 - 3 Building A No 3 Hongqi Xingye Road Zhongluotan Town, Baiyun District, Guangzhou