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Endoscopic bite block, basic - ARTG 463986

Access comprehensive regulatory information for Endoscopic bite block, basic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 463986 and sponsored by PlainSolution, manufactured by Jiangsu Vedkang Medical Science & Technology Co Ltd in China. The device registration started on October 09, 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.

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Class Is
ARTG 463986
Class Is
Endoscopic bite block, basic
ARTG ID: 463986
Good Name: PlainSolution - Endoscopic bite block, basic
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DJ Fang

DJ Fang

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Intended Purpose

Intended to be inserted into a patient's mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient's natural tendency to bite down on the instrument, thereby causing damage. The device will also protect the tongue and teeth of the patient during endoscopy. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
463986
Start Date
October 09, 2024
Effective Date
October 09, 2024
Sponsor
Manufacturer
Country
China
Address
No 52 Guoxiang Road Wujin Economic Development Zone, Changzhou Jiangsu, 213149