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Gown, operating room, single use

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 sponsored by O&M Halyard Australia Pty Ltd, manufactured by KenPax International Limited in HongKong. The device registration started on March 01, 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
Class I
Gown, operating room, single use
Australia TGA ARTG Registered Device
Good Name: O&M Halyard Australia Pty Ltd - Gown, operating room, single use
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Intended Purpose

Non-sterile surgical gowns used for medical procedure.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 01, 2024
Effective Date
March 01, 2024
Manufacturer
Country
HongKong
Address
Flat 5 5/F Wing on Plaza 62 Mody Road, Tsim Sha Tsui, Kowloon, 999077