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Gown, operating room, single use - ARTG 445674

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 Is is registered under ARTG number 445674 and sponsored by O&M Halyard Australia Pty Ltd, manufactured by KenPax International Limited in HongKong. The device registration started on April 11, 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 Is
ARTG 445674
Class Is
Gown, operating room, single use
ARTG ID: 445674
Good Name: O&M Halyard Australia Pty Ltd - Gown, operating room, single use
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Intended Purpose

Sterile surgical gown to be used in the Operating Theatre.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
445674
Start Date
April 11, 2024
Effective Date
April 11, 2024
Manufacturer
Country
HongKong
Address
Flat 5 5/F Wing on Plaza 62 Mody Road, Tsim Sha Tsui, Kowloon, 999077