Identity
- Trade Name
- Eversense® DMS FDA UDI
- Generic Name
- Implantable glucose monitoring system FDA UDI
- Device Name
- Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems. FDA UDI
- Model / Reference
- FG-5700-01-300 FDA UDI
- Description
- Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems. FDA UDI
Identifiers
- Catalog Number
- FG-5700-01-300 FDA UDI
- Primary DI / UDI-DI
- 00817491021878 FDA UDI
- FDA Product Code
- PHV FDA UDI
- GMDN Term
- Implantable glucose monitoring system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2120 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Eversense® DMS by Senseonics, Incorporated — 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
- Senseonics, Incorporated
Sources (1)
- FDA UDI 8ee77b35-44f4-408b-af7d-126e68f794b4 36 fields · synced Jun 6, 2026