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CUVIS-joint - Robotic surgical system - ARTG 371107

Access comprehensive regulatory information for CUVIS-joint - Robotic surgical system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 371107 and sponsored by Reveale Enterprises Pty Ltd, manufactured by Curexo Inc in South Korea. The device registration started on July 15, 2021.

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 371107
Class IIa
CUVIS-joint - Robotic surgical system
ARTG ID: 371107
Good Name: Reveale Enterprises Pty Ltd - CUVIS-joint - Robotic surgical system
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Intended Purpose

intended for use as a stereotaxic device for knee arthroplasty. It is to assist a surgeon in planning of pre-operation using medical diagnostic images obtained from patient and to provide orientation and reference information during intraoperative procedures. The surgical tools, under the supervision of the surgeon, perform the preoperative surgical plan.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
371107
Start Date
July 15, 2021
Effective Date
July 15, 2021
Manufacturer
Country
South Korea
Address
3rd/4th Floor 577 Gangnam-daero, Seocho-Gu, Seoul, 06530