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

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.

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TGA ARTG Official Data
Class III
Class III
i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone
Australia TGA ARTG Registered Device
Good Name: Xytide Biotech Pty Ltd- i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone
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Intended Purpose

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

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
Manufacturer
Country
South Korea
Address
80 Cheongjeong-ro Jijeong-myeon, Wonju-si, Gangwon-do, 26347