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Surgical/examination garment kit - ARTG 292936

Access comprehensive regulatory information for Surgical/examination garment kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 292936 and sponsored by Numedical Pty Ltd, manufactured by Medpro Healthcare Co Ltd in China. The device registration started on August 17, 2017.

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 Is
ARTG 292936
Class Is
Surgical/examination garment kit
ARTG ID: 292936
Good Name: Numedical Pty Ltd - Surgical/examination garment kit
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Intended Purpose

Surgical/examination garment kit; A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
292936
Start Date
August 17, 2017
Effective Date
August 17, 2017
Manufacturer
Country
China
Address
No 8 Xinghuo Road New Station Industrial Park Hefei, Anhui Province, 230022