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Endoscopic video image interpretive software - ARTG 381733

Access comprehensive regulatory information for Endoscopic video image interpretive software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 381733 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Linkverse S.R.L in Italy. The device registration started on January 05, 2022.

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 IIa
ARTG 381733
Class IIa
Endoscopic video image interpretive software
ARTG ID: 381733
Good Name: Medtronic Australasia Pty Ltd - Endoscopic video image interpretive software
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Intended Purpose

The device is intended to be process colonoscopy images, it is used by trained clinicians as an adjunct to colonoscopy for the purpose to highlighting regions suspected to have visual characteristic consistent with different types of mucosal abnormalities, colorectal lesions such as polyps and provided an estimation of the possible polyps histology.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
381733
Start Date
January 05, 2022
Effective Date
January 05, 2022
Manufacturer
Country
Italy
Address
Via Ostiense n 131/L, Roma, 00154