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Fixation system implantation kit, internal - ARTG 286655

Access comprehensive regulatory information for Fixation system implantation kit, internal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 286655 and sponsored by Australian Pacific Medical Pty Ltd, manufactured by Double Medical Technology Inc in China. The device registration started on March 12, 2017.

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 I
ARTG 286655
Class I
Fixation system implantation kit, internal
ARTG ID: 286655
Good Name: Australian Pacific Medical Pty Ltd - Fixation system implantation kit, internal
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Intended Purpose

A collection of instruments used for the placement of an internal fixation system into or onto bone or bones that may involve internal fixation (e.g., bones of limbs, spine, pelvis, craniomaxillofacia). The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, impactors) and sterilisation trays that are specific to the internal fixation system applied

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
286655
Start Date
March 12, 2017
Effective Date
March 12, 2017
Manufacturer
Country
China
Address
18 Shanbianhong East Road, Haicang District, Xiamen, 361026