Australia TGA ARTG record

Gown, operating room, single use

Australia TGA ARTG Registered Device · O&M Halyard Australia Pty Ltd · KenPax International Limited · Class Is · Started April 11, 2024

Good Name: O&M Halyard Australia Pty Ltd - Gown, operating room, single use

Device classification

Risk Class: Class Is
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 11, 2024
Effective Date: April 11, 2024

Sponsor

Name: O&M Halyard Australia Pty Ltd

Manufacturer

Name: KenPax International Limited
Country: HongKong
Address: Flat 5 5/F Wing on Plaza 62 Mody Road, Tsim Sha Tsui, Kowloon, 999077

Intended purpose

Sterile surgical gown to be used in the Operating Theatre.

About this record

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 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.