Glooko, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000023483
Glooko, Inc. is a medical device manufacturer based in the United States, with 13 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (FDA Class II and I; EU Class IIa and I) as of 13 Nov 2026.
- Devices
- 13
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 5
- FDA 510(k) 5
- FDA GUDID 5
- Device classes
- FDA Class II 7
- EU Class IIa 4
- EU Class I 1
- FDA Class I 1
- Top EMDN categories
- Sites and related companies
- MedEnvoy Global BV authorised representative
- Identifiers
- EUDAMED SRN US-MF-000023483
- DUNS 078605143
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- MedEnvoy Global BVNL
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.
Catalogue
Search and filter all 13 devicesCompany details
- EUDAMED SRN
- US-MF-000023483
- DUNS number
- 078605143
- EUDAMED status
- Active
- EUDAMED registered name
- Glooko, Inc.
- Registered address
- 579, University Avenue, 94301, Palo Alto [CA], United States
- Website
- www.glooko.com
- linkedin.com/company/glooko
- facebook.com/GlookoDeutschland
- PRRC contact
- Mary Beth McDonald
From the company website
Glooko connects patients, professionals and devices to simplify care, optimize workflows and deliver measurable results.
Frequently asked questions
How many devices does Glooko, Inc. have in the registry?
The registry currently lists 13 devices for Glooko, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glooko, Inc.'s devices?
Among its 13 most recently registered devices, Glooko, Inc. has devices listed in EUDAMED (5 devices), FDA 510(k) (5 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Glooko, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Glooko, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Glooko, Inc. in the registry?
The most recently registered devices listed for Glooko, Inc. include Cornerstones4Care® Powered by Glooko Mobile Application 1.xx, Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application 5.x, Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard 18.x and Glooko Web Application.