Australia flagARTG 443050

Gown, operating room, single use

ARTG ID: 443050 · Healthscope Operations PTY LTD · KenPax International Limited · Class Is · Started March 02, 2024

Good Name: Healthscope Operations PTY LTD - Gown, operating room, single use

Device classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
443050
Start Date
March 02, 2024
Effective Date
March 02, 2024
Sponsor
Manufacturer
Country
HongKong
Address
Flat 5 5/F Wing on Plaza 62 Mody Road, Tsim Sha Tsui, Kowloon, 999077
Intended purpose

To be worn over scrub suits during surgical procedures to protect both the patient and operating room personnel from the transfer of micro-organisms, body fluids and particulate material.

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 registered under ARTG number 443050 and sponsored by Healthscope Operations PTY LTD, manufactured by KenPax International Limited in HongKong. The device registration started on March 02, 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.

Free DatabasePowered by Pure Global AITGA ARTG Official Data