Data / Medical devices / Israel / Dreamed Diabetes Ltd
Dreamed Diabetes Ltd: FDA-registered device maker in Petah Tikva Tel Aviv, Israel, 4 510(k) clearances
Dreamed Diabetes Ltd is registered with the FDA (registration 3013922904) in Petah Tikva Tel Aviv, Israel. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013922904
- Address
- 14 Kaplan St. The Endocrinology Center Schneider Childrens Medical Center, Petah Tikva Tel Aviv, Israel, 4920235
- Owner or operator
- Dreamed Diabetes Ltd (10058055)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 1, 2018
- Registered through
- 2026
- Brand names listed
- Device, endo.digital platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | 1 | Manufacturer | accessdata.fda.gov |
| Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | QCC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2023 | K232722 | endo.digital Platform | QCC | Substantially Equivalent | DreaMed Diabetes, Ltd. | accessdata.fda.gov |
| September 28, 2021 | K210561 | Advisor Pro Platform | QCC | Substantially Equivalent | DreaMed Diabetes, Ltd. | accessdata.fda.gov |
| July 18, 2019 | K191370 | DreaMed Advisor Pro | QCC | Substantially Equivalent | DreaMed Diabetes, Ltd. | accessdata.fda.gov |
| June 12, 2018 | DEN170043 | DreaMed Advisor Pro | QCC | Unknown | DreaMed Diabetes, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Calculator, Drug Dose
- All makers of Continuous Glucose Monitor Retrospective Data Analysis Software
Updated October 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.