Australia TGA ARTG record

Orthosis, <specify>

Australia TGA ARTG Registered Device · Le Reve HealthCare Pty Ltd (AKA Caremax) · Shenzhen Osto Technology Company Limited · Class I · Started August 11, 2016

Good Name: Le Reve HealthCare Pty Ltd (AKA Caremax) - Orthosis, <specify>

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

Sponsor

Name: Le Reve HealthCare Pty Ltd (AKA Caremax)

Manufacturer

Name: Shenzhen Osto Technology Company Limited
Country: China
Address: 43 Longfeng Road Xinsheng Community Longgang Street Longgang District, Shenzhen City, Guangdong Province, 518116

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.

About this record

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.