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Surgical procedure kit, orthopaedic, single-use, non-medicated - ARTG 412830

Access comprehensive regulatory information for Surgical procedure kit, orthopaedic, single-use, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 412830 and sponsored by Actis Medical Pty Ltd, manufactured by CANWELL MEDICAL CO LTD in China. The device registration started on July 06, 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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Class IIa
ARTG 412830
Class IIa
Surgical procedure kit, orthopaedic, single-use, non-medicated
ARTG ID: 412830
Good Name: Actis Medical Pty Ltd - Surgical procedure kit, orthopaedic, single-use, non-medicated
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Intended Purpose

The single-use surgical instruments are necessary to perform surgical procedures including osteosynthesis and kyphoplasty. Guidewires and drills are used to prepare bones and facilitate the implantation of orthopaedic plate systems, intramedullary nailing systems, spinal fixation systems and kyphoplasty procedures.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
412830
Start Date
July 06, 2023
Effective Date
July 06, 2023
Manufacturer
Country
China
Address
No 466 South Xianhua Street High-Tech Industrial Zone Jinhua, Zhejiang, 321016