Eversense DMS

FDA UDI

Class I (US FDA UDI)

by Senseonics, Incorporated

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-5705-01-300 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-5705-01-300 FDA UDI
Primary DI / UDI-DI: 00817491023506 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Implantable glucose monitoring system

Eversense DMS by Senseonics, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable glucose monitoring system.

Eversense Adhesive Patches, 10-pack White — SENSEONICS, INCORPORATED · Class III
Eversense NOW Mobile App Android — SENSEONICS, INCORPORATED · Class II
Eversense 365 Mobile Application (iOS) — SENSEONICS, INCORPORATED · Class II
Eversense® Charging Accessories Pack — SENSEONICS, INCORPORATED · Class III
Eversense® Adhesive Patches, 30-Pack Clear — SENSEONICS, INCORPORATED · Class III
Eversense Mobile App iOS — SENSEONICS, INCORPORATED · Class III
Eversense Mobile App Android — SENSEONICS, INCORPORATED · Class III
Eversense E3 Adhesive Patches Kit, 180-pack — SENSEONICS, INCORPORATED · Class III

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Senseonics, Incorporated

Sources (1)

FDA UDI 585fc9ac-4931-478e-b0e2-eb72fcb2774a 35 fields · synced May 30, 2026