Identity
- Trade Name
- endo.digital FDA UDI
- Generic Name
- Ambulatory insulin infusion pump remote control/blood glucose analyser FDA UDI
- Device Name
- endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG) and to patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital gathers and analyses information inputted through the endo.digital Uploader or qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by endo.digital includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the endo.digital platform generates results containing summary data and recommendations for adjustments to the patient’s insulin therapy parameters, including a basal and bolus plan. endo.digital may also advise behavioral changes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patients. FDA UDI
- Model / Reference
- 02.XX.YY FDA UDI
- Description
- endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG) and to patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital gathers and analyses information inputted through the endo.digital Uploader or qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by endo.digital includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the endo.digital platform generates results containing summary data and recommendations for adjustments to the patient’s insulin therapy parameters, including a basal and bolus plan. endo.digital may also advise behavioral changes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patients. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 07290017735023 FDA UDI
- FDA Product Code
- OUG FDA UDIPHV FDA UDIQCC FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump remote control/blood glucose analyser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI862.2120 FDA UDI862.1358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Ambulatory insulin infusion pump remote control/blood glucose analyser
endo.digital by DreaMed Diabetes, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DreaMed Diabetes, Ltd.
Sources (1)
- FDA UDI 0aabefcf-ea49-44b8-a01b-ee497db06e07 34 fields · synced May 29, 2026