Australia TGA ARTG record

Clinical chemistry substrate IVDs

Australia TGA ARTG Registered Device · Pharmaco Australia Ltd · I-Sens Inc · Class IIa · Started September 08, 2017

Good Name: Pharmaco Australia Ltd - Clinical chemistry substrate IVDs

Device classification

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

Registration information

Start Date: September 08, 2017
Effective Date: September 08, 2017

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

Reagent cartridge and control solutions for use with a POCT HbA1c analyser.

About this record

Access comprehensive regulatory information for Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Pharmaco Australia Ltd, manufactured by I-Sens Inc in South Korea. The device registration started on September 08, 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.