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Light system sterile handle cover, single-use

Access comprehensive regulatory information for Light system sterile handle cover, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Denyers Pty Ltd T/a Denyers International, manufactured by Shanghai Everpure Medical Plastic Co Ltd in China. The device registration started on December 13, 2021.

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
Class Is
Light system sterile handle cover, single-use
Australia TGA ARTG Registered Device
Good Name: Denyers Pty Ltd T/a Denyers International - Light system sterile handle cover, single-use
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DJ Fang

DJ Fang

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Intended Purpose

A device used to provide a sterile physical barrier between the operating/examination light handle and the user. It is a flexible sleeve that attaches over the light handle, which is typically positioned in the centre of the light head. Surgical staff can change the position of the light(s) without violating their sterility. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 13, 2021
Effective Date
December 13, 2021
Manufacturer
Country
China
Address
No 2418 Tingfeng Rd Xinnong Town, Jinshan District, Shanghai, 201503