Australia TGA ARTG record

Soft-tissue anchor, non-bioabsorbable

Australia TGA ARTG Registered Device · Actis Medical Pty Ltd · CANWELL MEDICAL CO LTD · Class IIb · Started February 03, 2024

Good Name: Actis Medical Pty Ltd - Soft-tissue anchor, non-bioabsorbable

Device classification

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

Registration information

Start Date: February 03, 2024
Effective Date: February 03, 2024

Sponsor

Name: Actis Medical Pty Ltd

Manufacturer

Name: CANWELL MEDICAL CO LTD
Country: China
Address: No 466 South Xianhua Street High-Tech Industrial Zone Jinhua, Zhejiang, 321016

Intended purpose

A non-bioabsorbable, implantable anchor which is used for suture or soft-tissue fixation to bone during an orthopaedic procedure. Device is manufactured from PEEK.

About this record

Access comprehensive regulatory information for Soft-tissue anchor, non-bioabsorbable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Actis Medical Pty Ltd, manufactured by CANWELL MEDICAL CO LTD in China. The device registration started on February 03, 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.