Australia TGA ARTG record

DANA-i - Infusion pump, insulin, ambulatory

Australia TGA ARTG Registered Device · Managing Diabetes Pty Ltd · SOOIL Development Co Ltd · Class IIb · Started August 06, 2020

Good Name: Managing Diabetes Pty Ltd - DANA-i - Infusion pump, insulin, ambulatory

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: August 06, 2020
Effective Date: August 06, 2020

Sponsor

Name: Managing Diabetes Pty Ltd

Manufacturer

Name: SOOIL Development Co Ltd
Country: South Korea
Address: 62 Yonggu-daero 2325 beon-gil Gilgeung-gu, Yongin-si, Gyeonggi-do, 16922

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.

About this record

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 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.