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Suture, polyethylene

Access comprehensive regulatory information for Suture, polyethylene in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Life Healthcare Pty Ltd, manufactured by Hangzhou Rejoin Mastin Medical Device Co Ltd in China. The device registration started on December 19, 2019.

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 IIb
Class IIb
Suture, polyethylene
Australia TGA ARTG Registered Device
Good Name: Life Healthcare Pty Ltd - Suture, polyethylene
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Intended Purpose

A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g polyethylene) intended to join (i.e, approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. tis not a barbed suture and does not include antimicrobial agents/ materials. This is a single-use device intended to be used in a sterile condition.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 19, 2019
Effective Date
December 19, 2019
Manufacturer
Country
China
Address
Floors 1st and 2nd 101B No 22 Xinyan Road Yuhang Economic Development Zone, Hangzhou, Zhejiang, 311100