DANA-i - Infusion pump, insulin, ambulatory
ARTG ID: 340938 · 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
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 340938
- Start Date
- August 06, 2020
- Effective Date
- August 06, 2020
- Country
- South Korea
- Address
- 62 Yonggu-daero 2325 beon-gil Gilgeung-gu, Yongin-si, Gyeonggi-do, 16922
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.
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.