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Roceso DynaX Glove - Orthosis, arm, hand, unit - ARTG 462285

Access comprehensive regulatory information for Roceso DynaX Glove - Orthosis, arm, hand, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 462285 and sponsored by Aerobe Pty Ltd, manufactured by ROCESO TECHNOLOGIES PTE LTD in Singapore. The device registration started on September 17, 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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Class I
ARTG 462285
Class I
Roceso DynaX Glove - Orthosis, arm, hand, unit
ARTG ID: 462285
Good Name: Aerobe Pty Ltd - Roceso DynaX Glove - Orthosis, arm, hand, unit
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Intended Purpose

DynaXTM Glove is a dynamic extension glove designed to aid neurological and orthopaedic patients in achieving optimal finger and thumb extension through its patented fabric spring technology. It facilitates the positioning of fingers into extension, thereby preparing patients for functional activities.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462285
Start Date
September 17, 2024
Effective Date
September 17, 2024
Sponsor
Manufacturer
Country
Singapore
Address
83 Science Park Drive #04-01 Curie, Singapore, Singapore, 118258