Australia TGA ARTG record

Gown, operating room, single use

Australia TGA ARTG Registered Device · KRIA ENTERPRISES PTY LTD · Feixi Hongwei Medical Devices Co Ltd · Class I · Started June 28, 2024

Good Name: KRIA ENTERPRISES PTY LTD - Gown, operating room, single use

Device classification

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

Registration information

Start Date: June 28, 2024
Effective Date: June 28, 2024

Sponsor

Name: KRIA ENTERPRISES PTY LTD

Manufacturer

Name: Feixi Hongwei Medical Devices Co Ltd
Country: China
Address: 2F Building 6 Clanggu Road Feixi Country, Hefei City, Auhui Province

Intended purpose

A non-sterile gown intended to be worn by patients in a clinical setting during hospitalization or during examination in a doctor's office. This is a single-use device.

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 I is sponsored by KRIA ENTERPRISES PTY LTD, manufactured by Feixi Hongwei Medical Devices Co Ltd in China. The device registration started on June 28, 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.