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DANA-i - Infusion pump, insulin, ambulatory - ARTG 340938

Access comprehensive regulatory information for DANA-i - Infusion pump, insulin, ambulatory in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 340938 and sponsored by Managing Diabetes Pty Ltd, manufactured by SOOIL Development Co Ltd in South Korea. The device registration started on August 06, 2020.

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 IIb
ARTG 340938
Class IIb
DANA-i - Infusion pump, insulin, ambulatory
ARTG ID: 340938
Good Name: Managing Diabetes Pty Ltd - DANA-i - Infusion pump, insulin, ambulatory
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Intended Purpose

This device is designed for the continuous delivery of insulin to people with diabetes. ACE (alternate control enabled) with encrypted secure v5 Bluetooth to approved control algorithm or CGM.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
340938
Start Date
August 06, 2020
Effective Date
August 06, 2020
Manufacturer
Country
South Korea
Address
62 Yonggu-daero 2325 beon-gil Gilgeung-gu, Yongin-si, Gyeonggi-do, 16922