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Clinical chemistry substrate IVDs

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Clinical chemistry substrate IVDs
Australia TGA ARTG Registered Device
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
Start Date
September 08, 2017
Effective Date
September 08, 2017
Manufacturer
Country
South Korea
Address
43 Banpo-daero 28-gil, Seocho-gu, Seoul, 06646