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Medical equipment drape, single-use - ARTG 411294

Access comprehensive regulatory information for Medical equipment drape, 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 411294 and sponsored by Imaging Solutions Pty Ltd, manufactured by Exact Medical Manufacturing Inc in China. The device registration started on June 26, 2023.

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 411294
Class Is
Medical equipment drape, single-use
ARTG ID: 411294
Good Name: Imaging Solutions Pty Ltd - Medical equipment drape, single-use
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Intended Purpose

A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment and/or equipment components. It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
411294
Start Date
June 26, 2023
Effective Date
June 26, 2023
Manufacturer
Country
China
Address
No 21 Qingjiang Road Xinbei District, Changzhou, Jiangsu Province, 213000