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Clinical chemistry substrate IVDs - ARTG 227133

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 IIb is registered under ARTG number 227133 and sponsored by IBD Medical Trading Pty Ltd, manufactured by LabStyle Innovations Ltd in Israel. The device registration started on August 21, 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 227133
Class IIb
Clinical chemistry substrate IVDs
ARTG ID: 227133
Good Name: IBD Medical Trading Pty Ltd - Clinical chemistry substrate IVDs
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Intended Purpose

The Dario Blood Glucose Monitoring System is intended for monitoring blood glucose levels for patients with Type I or Type II diabetes. The system consists of a meter, test strips and control solution, lancing device and lancets and a software application.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
227133
Start Date
August 21, 2014
Effective Date
August 21, 2014
Manufacturer
Country
Israel
Address
8 Hatokhen, North Industrial Park, Caesaria, 3088900