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Sign in to claim this brandGlooko, Inc.
United States·US-MF-000023483
Last updated September 18, 2026
About
Glooko connects patients, professionals and devices to simplify care, optimize workflows and deliver measurable results.
Translated from the manufacturer's own website. Source
What Glooko, Inc. makes
Glooko develops clinical management support software for diabetes care, including mobile applications for insulin dosing (Android and iOS), web-based dashboards, and logbook tools. These tools integrate with continuous glucose monitoring devices and transmitters to track and analyze patient data, such as glucose readings and insulin administration records. The portfolio also includes specialized analytics for healthcare providers, such as EndoTool IV Cloud, which supports treatment planning and decision-making.
The company’s products are regulated as Class I, Class II, and Class IIa medical devices, with some entries listed in the EU’s EUDAMED database and the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 579, University Avenue, Palo Alto [CA], United States
- Website
- www.glooko.com
- linkedin.com/company/glooko
- facebook.com/GlookoDeutschland
- [email protected]
- Phone
- —
- PRRC Contact
- Mary Beth McDonald
- EUDAMED SRN
- US-MF-000023483
- FDA FEI Number
- —
- DUNS Number
- 078605143
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cornerstones4Care® Powered by Glooko Mobile Application | 1.xx | FDA UDI | Class I | Active |
| Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application | 5.x | FDA UDI | Class II | Active |
| Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard | 18.x | FDA UDI | Class II | Active |
| Glooko Web Application | REF-0001 | EUDAMEDFDA UDI | Class IIa | Active |
| Glooko Device System For Glooko Logbook+ Application | K130886 | FDA 510(k) | Class II | Active |
| Glooko Mobile Insulin Dosing System | K171450 | FDA 510(k) | Class II | Active |
| Glooko Logbook Charts | K122142 | FDA 510(k) | Class II | Active |
| EndoTool IV Cloud 1.0 | K260910 | FDA 510(k) | Class II | Active |
| Glooko Device System For Glooko Application | K132272 | FDA 510(k) | Class II | Active |
| Glooko Transmitter | REF-0003 | EUDAMED | Class I | Active |
| Glooko XT | REF-0010 | EUDAMED | Class IIa | Active |
| Glooko Mobile Application | REF-0002 | EUDAMEDFDA UDI | Class IIa | Active |
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