Australia TGA ARTG record

Prosthesis, external, leg, <specify>

Australia TGA ARTG Registered Device · Orthotic & Prosthetic Centre Pty Ltd · Xiamen J-Brace Medical Equipment Co Ltd · Class I · Started December 19, 2023

Good Name: Orthotic & Prosthetic Centre Pty Ltd - Prosthesis, external, leg, <specify>

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 19, 2023
Effective Date: December 19, 2023

Sponsor

Name: Orthotic & Prosthetic Centre Pty Ltd

Manufacturer

Name: Xiamen J-Brace Medical Equipment Co Ltd
Country: China
Address: S2 Room 4F No 186 Yuehua Road Huli District, Xiamen, Fujian

Intended purpose

GMDN 35269 Prosthesis, external, leg Intended purpose - prosthesis lower limb

About this record

Access comprehensive regulatory information for Prosthesis, external, leg, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Orthotic & Prosthetic Centre Pty Ltd, manufactured by Xiamen J-Brace Medical Equipment Co Ltd in China. The device registration started on December 19, 2023.

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.