Australia flagARTG 419445

Medical equipment drape, single-use

ARTG ID: 419445 · Defries Industries Pty Ltd · Exact Medical Manufacturing Inc · Class Is · Started August 22, 2023

Good Name: Defries Industries Pty Ltd - Medical equipment drape, single-use

Device classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
419445
Start Date
August 22, 2023
Effective Date
August 22, 2023
Sponsor
Manufacturer
Country
China
Address
No 21 Qingjiang Road Xinbei District, Changzhou, Jiangsu Province, 213000
Intended purpose

Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate from microbial and other contamination. A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). 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.

About this record

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 419445 and sponsored by Defries Industries Pty Ltd, manufactured by Exact Medical Manufacturing Inc in China. The device registration started on August 22, 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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