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Clinical chemistry substrate IVDs - ARTG 293668

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 registered under ARTG number 293668 and 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.

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Class IIa
ARTG 293668
Class IIa
Clinical chemistry substrate IVDs
ARTG ID: 293668
Good Name: Pharmaco Australia Ltd - Clinical chemistry substrate IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
293668
Start Date
September 08, 2017
Effective Date
September 08, 2017
Manufacturer
Country
South Korea
Address
43 Banpo-daero 28-gil, Seocho-gu, Seoul, 06646