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Orthosis, <specify>

Access comprehensive regulatory information for Orthosis, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Le Reve HealthCare Pty Ltd (AKA Caremax), manufactured by Shenzhen Osto Technology Company Limited in China. The device registration started on August 11, 2016.

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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TGA ARTG Official Data
Class I
Class I
Orthosis, <specify>
Australia TGA ARTG Registered Device
Good Name: Le Reve HealthCare Pty Ltd (AKA Caremax) - Orthosis, <specify>
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Intended Purpose

Brace belt, designed to be worn around the waist over light clothing to provide support. A device intended to be used to support, align, prevent, or correct bodily deformities,injuries, to improve the function of movable parts of the body and to relieve lower back related pains.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 11, 2016
Effective Date
August 11, 2016
Manufacturer
Country
China
Address
43 Longfeng Road Xinsheng Community Longgang Street Longgang District, Shenzhen City, Guangdong Province, 518116