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Gastroduodenoscope, flexible, ultrasonic - ARTG 464770

Access comprehensive regulatory information for Gastroduodenoscope, flexible, ultrasonic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 464770 and sponsored by PlainSolution, manufactured by SonoScape Medical Corp in China. The device registration started on October 17, 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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TGA ARTG Official Data
Class IIa
ARTG 464770
Class IIa
Gastroduodenoscope, flexible, ultrasonic
ARTG ID: 464770
Good Name: PlainSolution - Gastroduodenoscope, flexible, ultrasonic
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Intended Purpose

It is an endoscope combined with an ultrasound probe used to examine the upper gastrointestinal tract.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464770
Start Date
October 17, 2024
Effective Date
October 17, 2024
Sponsor
Manufacturer
Country
China
Address
Room 201 & 202 12th Building Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road Yuehai Subdistrict Nanshan District, Shenzhen Guangdong, China, 518057