ARTG 227287

Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs

ARTG ID: 227287 · Pharmaco Australia Ltd · I-Sens Inc · Class IIb · Started August 27, 2014

Good Name: Pharmaco Australia Ltd - Clinical chemistry substrate IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

ARTG ID: 227287
Start Date: August 27, 2014
Effective Date: July 20, 2016

Sponsor

Name: Pharmaco Australia Ltd

Manufacturer

Name: I-Sens Inc
Country: South Korea
Address: 43 Banpo-daero 28-gil, Seocho-gu, Seoul, 06646

Intended purpose

For the quantitative measurement of glucose or ketones in blood

About this record

Access comprehensive regulatory information for Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 227287 and sponsored by Pharmaco Australia Ltd, manufactured by I-Sens Inc in South Korea. The device registration started on August 27, 2014.

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.