Australia TGA ARTG record

DemeDIOX - Suture, polydioxanone

Australia TGA ARTG Registered Device · Avacare Australia Pty Ltd · DemeTECH Corp · Class III · Started January 17, 2023

Good Name: Avacare Australia Pty Ltd - DemeDIOX - Suture, polydioxanone

Device classification

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

Registration information

Start Date: January 17, 2023
Effective Date: January 17, 2023

Sponsor

Name: Avacare Australia Pty Ltd

Manufacturer

Name: DemeTECH Corp
Country: United States of America
Address: 14175 NW 60th Avenue, Miami Lakes, FL, 33014

Intended purpose

POLYDIOXANONE monofilament synthetic absorbable sutures are indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. DemeDIOX is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where the combination of an absorbable suture and extend wound support (up to six weeks) is desirable.

About this record

Access comprehensive regulatory information for DemeDIOX - Suture, polydioxanone in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Avacare Australia Pty Ltd, manufactured by DemeTECH Corp in United States of America. The device registration started on January 17, 2023.

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.