Pure Global

Flexible video bronchoscope, single-use

Access comprehensive regulatory information for Flexible video bronchoscope, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Koala Medical Pty Ltd, manufactured by Shenzhen HugeMed Medical Technical Development Co Ltd in China. The device registration started on July 12, 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 IIa
Class IIa
Flexible video bronchoscope, single-use
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Flexible video bronchoscope, single-use
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

The product is a single-use sterile flexible endoscope for endoscopic surgery and examination in the anatomy of nasal cavity and upper respiratory tract. The endoscope is used to provide images through an endoscopy video processor manufactured by HugeMed. The single-use flexible bronchoscope is connected to an endoscopy video processor manufactured by HugeMed, and used in conjunction with other endoscopic accessories for the examination and treatment of trachea and bronchus in adults.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 12, 2023
Effective Date
July 12, 2023
Manufacturer
Country
China
Address
416-1 516-1 Building 2 No 1 Mawu Road Baoan Community Yuanshan Street, Longgang District Shenzhen, Guangdong, 518115