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Flexible video ureterorenoscope, single-use

Access comprehensive regulatory information for Flexible video ureterorenoscope, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by AMBU Australia Pty Ltd, manufactured by Ambu AS in Denmark. The device registration started on January 19, 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
Class IIa
Flexible video ureterorenoscope, single-use
Australia TGA ARTG Registered Device
Good Name: AMBU Australia Pty Ltd - Flexible video ureterorenoscope, single-use
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Intended Purpose

The aScope 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual guidance in the upper urinary tract. aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 19, 2024
Effective Date
January 19, 2024
Manufacturer
Country
Denmark
Address
Baltorpbakken 13, Ballerup, DK-2750