Pure Global

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 IntraSpace Pty Ltd, manufactured by Cross Protection M Sdn Bhd in Malaysia. The device registration started on May 25, 2020.

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 Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Gown, operating room, single use
Australia TGA ARTG Registered Device
Good Name: IntraSpace Pty Ltd - Gown, operating room, single use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

used during surgical procedures to protect both the patient and operating room personnel from the transfer of micro-organisms, body fluids and particulate material

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 25, 2020
Effective Date
May 25, 2020
Sponsor
Manufacturer
Country
Malaysia
Address
11 Jalan Perindustrian 5 Batu 5 1/2 Off Jalan Haji Abdul Manan, Klang, Selangor, 41050