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Ambulatory insulin infusion pump software, patient-dosing - ARTG 383774

Access comprehensive regulatory information for Ambulatory insulin infusion pump software, patient-dosing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 383774 and sponsored by Managing Diabetes Pty Ltd, manufactured by SOOIL Development Co Ltd in South Korea. The device registration started on February 09, 2022.

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 383774
Class IIb
Ambulatory insulin infusion pump software, patient-dosing
ARTG ID: 383774
Good Name: Managing Diabetes Pty Ltd - Ambulatory insulin infusion pump software, patient-dosing
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Intended Purpose

AnyDANA is a Mobile Phone Application paired with the DANA insulin pump. AnyDANA-A is for Android based device and AnyDANA-i is for iOS based device. Using a smart phone application improves the visibility and usability of the DANA insulin pumps. The main functions of AnyDANA: 1. Adjusting the settings within the DANA insulin pump. ✓ Basal profile ✓ Bolus rates including CIR and CF rates ✓ Personalizing the insulin pump User Options (beep, vibrate/alarm sounds) ✓ Setting time 2. Review the data and history stored in the DANA insulin pump ✓ Bolus and Basal history, daily totals, Alarms, suspend history, etc. 3. Remotely and discretely deliver insulin  Deliver (start and stop) bolus from phone  Set or stop temporary basal rates  Suspend or resume basal delivery The DANA Diabecare Insulin Pump and AnyDANA Application are intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
383774
Start Date
February 09, 2022
Effective Date
February 09, 2022
Manufacturer
Country
South Korea
Address
62 Yonggu-daero 2325 beon-gil Gilgeung-gu, Yongin-si, Gyeonggi-do, 16922