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Gown, operating room, single use - ARTG 464948

Access comprehensive regulatory information for Gown, operating room, 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 464948 and sponsored by Wiselink Group Pty Ltd, manufactured by Cobes Industries Hefei Co Ltd in China. The device registration started on October 18, 2024.

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 464948
Class I
Gown, operating room, single use
ARTG ID: 464948
Good Name: Wiselink Group Pty Ltd - Gown, operating room, single use
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Intended Purpose

The surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material; or are used for general isolation in outpatient clinics, wards, inspection rooms of medical institutions, etc. This product is non-sterile.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464948
Start Date
October 18, 2024
Effective Date
October 18, 2024
Manufacturer
Country
China
Address
No 39 Liaoyuan Road Xincheng Development Zone, Hefei, Anhui