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Endoscopic video image processor - ARTG 475905

Access comprehensive regulatory information for Endoscopic video image processor in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 475905 and sponsored by MedEnvoy Global Pty Ltd, manufactured by Santa Barbara Imaging Systems Inc in United States of America. The device registration started on January 16, 2025.

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 I
ARTG 475905
Class I
Endoscopic video image processor
ARTG ID: 475905
Good Name: MedEnvoy Global Pty Ltd - Endoscopic video image processor
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Intended Purpose

The Pixa 4K HDR Camera Control Unit with integrated LED light source and image/video capture is intended to be used when performing a variety of minimally surgical procedures for general medical visualization and video archive applications. The camera Control Unit processes video data inputs for display on viewing monitors. Displayed images and videos may be captured and stored internally and/or transmitted externally via a variety of means, controlled through the device's integrated touch panel or an optional secondary remote control mobile device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
475905
Start Date
January 16, 2025
Effective Date
January 16, 2025
Manufacturer
Country
United States of America
Address
Suite 101 340 Storke Road, Goleta, CA, 93117