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Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs - ARTG 227287

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.

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Class IIb
ARTG 227287
Class IIb
Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs
ARTG ID: 227287
Good Name: Pharmaco Australia Ltd - Clinical chemistry substrate IVDs
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Intended Purpose

For the quantitative measurement of glucose or ketones in blood

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
Manufacturer
Country
South Korea
Address
43 Banpo-daero 28-gil, Seocho-gu, Seoul, 06646