Australia TGA ARTG record

Ambulatory insulin infusion pump software, patient-dosing

Australia TGA ARTG Registered Device · Managing Diabetes Pty Ltd · SOOIL Development Co Ltd · Class IIb · Started February 09, 2022

Good Name: Managing Diabetes Pty Ltd - Ambulatory insulin infusion pump software, patient-dosing

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: February 09, 2022
Effective Date: February 09, 2022

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

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.

About this record

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 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.