Australia TGA ARTG record

Orthopaedic fixation suture button

Australia TGA ARTG Registered Device · Australian Pacific Medical Pty Ltd · Double Medical Technology Inc · Class IIb · Started March 25, 2024

Good Name: Australian Pacific Medical Pty Ltd - Orthopaedic fixation suture button

Device classification

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

Registration information

Start Date: March 25, 2024
Effective Date: March 25, 2024

Sponsor

Name: Australian Pacific Medical Pty Ltd

Manufacturer

Name: Double Medical Technology Inc
Country: China
Address: 18 Shanbianhong East Road, Haicang District, Xiamen, 361026

Intended purpose

A System used for fixation of tendons and ligaments (soft-tissue) to bone in Orthopaedic surgery. This is a single-use, non-absorbable device.

About this record

Access comprehensive regulatory information for Orthopaedic fixation suture button in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Australian Pacific Medical Pty Ltd, manufactured by Double Medical Technology Inc in China. The device registration started on March 25, 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.