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DemeDIOX - Suture, polydioxanone

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.

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TGA ARTG Official Data
Class III
Class III
DemeDIOX - Suture, polydioxanone
Australia TGA ARTG Registered Device
Good Name: Avacare Australia Pty Ltd - DemeDIOX - Suture, polydioxanone
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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.

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
Manufacturer
Country
United States of America
Address
14175 NW 60th Avenue, Miami Lakes, FL, 33014