Australia TGA ARTG record

Lancet, automatic

Australia TGA ARTG Registered Device · Plexus RA Pty Ltd · Bionime Corporation · Class I · Started April 27, 2013

Good Name: Plexus RA Pty Ltd- Lancet, automatic

Device classification

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

Registration information

Start Date: April 27, 2013
Effective Date: April 27, 2013

Sponsor

Name: Plexus RA Pty Ltd

Manufacturer

Name: Bionime Corporation
Country: Taiwan
Address: No 100 Sec2 Daqing Street South Dist, Taichung City, Taichung City, 40242

Intended purpose

A non-sterile instrumnet designed for capillary blood specimen taking by a diabetic patient. It is designed to automatically inject a disposable lancet tip into the skin to a predetermined depth enabling blood to squeezed out of the puncture site to obtain the specimen for analysis. This is a reusable device, however the disposable lancet tip is a single-use device.

About this record

Access comprehensive regulatory information for Lancet, automatic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Plexus RA Pty Ltd, manufactured by Bionime Corporation in Taiwan. The device registration started on April 27, 2013.

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.