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Bioinductive Implant with Arthroscopic Delivery System - Multi-purpose surgical mesh, collagen - ARTG 384118

Access comprehensive regulatory information for Bioinductive Implant with Arthroscopic Delivery System - Multi-purpose surgical mesh, collagen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 384118 and sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc Endoscopy Division in United States of America. The device registration started on February 16, 2022.

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 III
ARTG 384118
Class III
Bioinductive Implant with Arthroscopic Delivery System - Multi-purpose surgical mesh, collagen
ARTG ID: 384118
Good Name: Smith & Nephew Pty Ltd - Bioinductive Implant with Arthroscopic Delivery System - Multi-purpose surgical mesh, collagen
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Intended Purpose

The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
384118
Start Date
February 16, 2022
Effective Date
May 02, 2024
Manufacturer
Country
United States of America
Address
150 Minuteman Road, ANDOVER, MA, 01810-1031