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Wound closure set, topical - ARTG 441854

Access comprehensive regulatory information for Wound closure set, topical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 441854 and sponsored by Kate Harding Medical Services, manufactured by Zhejiang Longterm Medical Technology Co Ltd in China. The device registration started on February 21, 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.

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Class IIa
ARTG 441854
Class IIa
Wound closure set, topical
ARTG ID: 441854
Good Name: Kate Harding Medical Services - Wound closure set, topical
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Intended Purpose

The device is a sterile, single-use dermally applied, non-surgical wound closure system intended for the topical approximation of easily aligned skin edges of wounds. The device is composed of a medical-grade, pressure-sensitive adhesive backing made from either polyurethane (PU) film or a porous nonwoven fabric, paired with a polypropylene fastener mechanism and liner. This design allows for a non-invasive, sutureless closure, significantly reducing tissue trauma and the likelihood of scarring while enhancing patient comfort and ease of use. The hasp fastener mechanism allows secure and adjustable tension control for quick & easy application. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with, but not in place of deep dermal stitches

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
441854
Start Date
February 21, 2024
Effective Date
February 21, 2024
Manufacturer
Country
China
Address
ShuangShan Road 277 Fuxi Street, Huzhou City Deqing County, Zhejiang Province, 313200