Diary Mobile App

The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal…

Registry build 21.09.26

The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider. The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan. The Diary Mobile app is suited for both iPhone and Android users. The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information. The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NDC
Manufacturer City Province Registered as Device types
Sanmina Kunshan Jiangsu Contract manufacturer 15
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44

Record

Regulatory record for Diary Mobile App
Listed by Dreamed Diabetes Ltd, Israel
FDA product code NDC
Device type Calculator, Drug Dose
Device class Class 2
Regulation 21 CFR 868.1890
Establishment Complaint-file establishment, Manufacturer
510(k) K210561
Record published 2022-10-26
Record revised 2026-07-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Diary Mobile App
Catalogue number Size Status
02.XX.YY In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welldoc Welldoc 16
Insulia Voluntis 6
Healthfirst Cares Rx Welldoc 6
Bluestar Welldoc 6
Healthfirst Cares Welldoc 5
Conifer Connect Diabetes Welldoc 5
Welldoc Rx Welldoc 5
LivingConnected Diabetes Rx Welldoc 5
Bluestar Rx Welldoc 5
Conifer Connect Diabetes Rx Welldoc 5
inpen™ Medtronic Minimed 5
TempoSmart Welldoc 4

Showing 12 of 36. All products under Calculator, Drug Dose

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer