ARTG 413382Flexible video bronchoscope, single-use
ARTG ID: 413382 · Koala Medical Pty Ltd · Shenzhen HugeMed Medical Technical Development Co Ltd · Class IIa · Started July 12, 2023
Good Name: Koala Medical Pty Ltd - Flexible video bronchoscope, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 413382
- Start Date
- July 12, 2023
- Effective Date
- July 12, 2023
- Country
- China
- Address
- 416-1 516-1 Building 2 No 1 Mawu Road Baoan Community Yuanshan Street, Longgang District Shenzhen, Guangdong, 518115
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.
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 registered under ARTG number 413382 and 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.