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Surgical Navigation Robot - Robot, surgical, navigation unit - ARTG 341674

Access comprehensive regulatory information for Surgical Navigation Robot - Robot, surgical, navigation unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 341674 and sponsored by Reveale Enterprises Pty Ltd, manufactured by Curexo Inc in South Korea. The device registration started on August 17, 2020.

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 341674
Class IIa
Surgical Navigation Robot - Robot, surgical, navigation unit
ARTG ID: 341674
Good Name: Reveale Enterprises Pty Ltd - Surgical Navigation Robot - Robot, surgical, navigation unit
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Intended Purpose

intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous surgical procedures if the required markers and rigid patient anatomy can be identified on O-arm or C-arm

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
341674
Start Date
August 17, 2020
Effective Date
August 17, 2020
Manufacturer
Country
South Korea
Address
3rd/4th Floor 577 Gangnam-daero, Seocho-Gu, Seoul, 06530