Australia TGA ARTG record

i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone

Australia TGA ARTG Registered Device · Xytide Biotech Pty Ltd · Hyundae Meditech Co Ltd · Class III · Started May 12, 2021

Good Name: Xytide Biotech Pty Ltd- i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone

Device classification

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

Registration information

Start Date: May 12, 2021
Effective Date: May 12, 2021

Sponsor

Name: Xytide Biotech Pty Ltd

Manufacturer

Name: Hyundae Meditech Co Ltd
Country: South Korea
Address: 80 Cheongjeong-ro Jijeong-myeon, Wonju-si, Gangwon-do, 26347

Intended purpose

Intended to fixate sub dermal tissue in an elevated position in plastic and reconstructive surgery.

About this record

Access comprehensive regulatory information for i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Xytide Biotech Pty Ltd, manufactured by Hyundae Meditech Co Ltd in South Korea. The device registration started on May 12, 2021.

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.