Pure Global

Non-implantable needle guide, single-use

Access comprehensive regulatory information for Non-implantable needle guide, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Innologic Pty Ltd, manufactured by Suzhou Leapmed Healthcare Corporation in China. The device registration started on July 20, 2020.

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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TGA ARTG Official Data
Class Is
Class Is
Non-implantable needle guide, single-use
Australia TGA ARTG Registered Device
Good Name: Innologic Pty Ltd - Non-implantable needle guide, single-use
Pure Global
DJ Fang

DJ Fang

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Pricing
Intended Purpose

A sterile device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures including but not limited to urethral injections, transrectal or transperineal prostate biopsy, ultrasound-guided percutaneous punctures and nerve blocks, electromagnetic device tracking systems and breast biopsies. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 20, 2020
Effective Date
July 20, 2020
Manufacturer
Country
China
Address
Wuzhong Science Park No2 and No3 Building 38# North Guandu Road Wuzhong District, Suzhou City, Jiangsu, 215100