GlucoCare

GlucoCare Intensive Glycemic Control System

Registry build 21.09.26
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 GlucoCare
Listed by Pronia Medical Systems, United States
FDA product code NDC
Device type Calculator, Drug Dose
Device class Class 2
Regulation 21 CFR 868.1890
Establishment Manufacturer
510(k) K081388
Record published 2022-08-02
Record revised 2026-07-21 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for GlucoCare
Catalogue number Size Status
2.X 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