Australia TGA ARTG record

Orthopaedic cement preparation/delivery kit

Australia TGA ARTG Registered Device · E4 Surgical Pty Ltd · Dragon Crown Medical Co Ltd · Class IIa · Started June 03, 2022

Good Name: E4 Surgical Pty Ltd - Orthopaedic cement preparation/delivery kit

Device classification

Risk Class: Class IIa
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: June 03, 2022
Effective Date: June 03, 2022

Sponsor

Name: E4 Surgical Pty Ltd

Manufacturer

Name: Dragon Crown Medical Co Ltd
Country: China
Address: B1 F7 F8 Engineering and Technology Center Building No 978, Tianchen Road High-tech Development Zone Jinan, Shandong

Intended purpose

Sterile single use prepartaion instruments for bone filling container kit.

About this record

Access comprehensive regulatory information for Orthopaedic cement preparation/delivery kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by E4 Surgical Pty Ltd, manufactured by Dragon Crown Medical Co Ltd in China. The device registration started on June 03, 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.