eversensediabetes.comEversense Continuous Glucose Monitoring System
Senseonics, Incorporated
Senseonics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009862700 | 3009862700 | Senseonics, Inc. | 1 | N | 2026-01-01 | 20451 Seneca Meadows Pkwy Germantown MD US 20876 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00817491022936 | Eversense E3 Smart Transmitter Kit - Provider Purchase - Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card. | 844-736-7348 | support@eversensediabetes.com |
| 00817491022950 | Eversense E3 Sensor Kit - DME - Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder. | 844-736-7348 | support@eversensediabetes.com |
| 00817491022967 | Eversense E3 Sensor Kit - Retail - Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder. | 844-736-7348 | support@eversensediabetes.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 158946 | 1559702373 | P160048 | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM | QCD | 2018-06-21 |
| 158946 | 1694999684 | K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | SBA | 2024-09-16 |
| 158946 | 1294220442 | ||||
| 158946 | 1831403241 |
Product Codes Associated With Registrations#
PMA#
Eversense Continuous Glucose Monitoring System
Senseonics, Incorporated
Eversense Continuous Glucose Monitoring System
Senseonics, Incorporated
Eversense Continuous Glucose Monitoring System
Senseonics, Incorporated
Eversense Continuous Glucose Monitoring System
Senseonics, Incorporated
Eversense Continuous Glucose Monitoring System
Senseonics, Incorporated
Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers
SENSEONICS, INCORPORATED
Eversense Continuous Glucose Monitoring System
SENSEONICS, INCORPORATED
Eversense Continuous Glucose Monitoring System
SENSEONICS, INCORPORATED
Eversense Continuous Glucose Monitoring System
SENSEONICS, INCORPORATED
Eversense Continuous Glucose Monitoring System
SENSEONICS, INCORPORATED
Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
SENSEONICS, INCORPORATED
Eversense Continuous Glucose Monitoring System
SENSEONICS, INCORPORATED
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
SENSEONICS, INCORPORATED
PMN#
Eversense 365 Continuous Glucose Monitoring (CGM) System
Senseonics, Incorporated
GUDID#
Grafted Eversense 365 Sensor and Holder in Sealed Pouch, Global - Pouch contains one Eversense 365 Sensor in a Sensor holder.
2026-04-14
Eversense Mobile App Android - Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
2022-03-10
Eversense Mobile App iOS - Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trendinformation, and alerts.
2022-03-10
Eversense E3 Pouch Containing Sensor and Holder - Eversense E3 Pouch contains one Eversense E3 Sensor in a Sensor holder.
2022-03-10
Eversense E3 Sensor Kit – Provider Purchase - Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
2022-03-10
Eversense E3 Sensor Kit - Retail - Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
2022-03-10
Eversense E3 Sensor Kit - DME - Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
2022-03-10
Eversense E3 Smart Transmitter Kit - Provider Purchase - Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
2022-03-10
Eversense E3 Smart Transmitter Kit - Retail - Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
2022-03-10
Eversense E3 Smart Transmitter Kit - Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
2022-03-10
Eversense E3 Insertion Tools Kit - Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
2022-03-10
Eversense E3 Adhesive Patches Kit, 180-pack - Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. The kit contains five 30-packs of white patches and one 30-pack of clear patches.
2022-03-10
Eversense 365 Smart Transmitter Kit (Provider Purchase) - Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
2026-02-25
Eversense 365 Smart Transmitter Kit (Retail) - Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
2026-02-25
Eversense 365 Smart Transmitter Kit (DME) - Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
2026-02-25
Eversense® Charging Accessories Pack - Eversense® Charging Accessories Pack contains the Charging Cradle, US Configuration Power Supply and a USB Cable.
2018-10-09
Eversense® DMS Pro - The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
2018-07-16
Eversense® DMS - 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.
2018-07-16
Eversense® Adhesive Patches, 10-pack Clear - Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
2018-07-16
Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear - Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
2018-07-16
Eversense® Adhesive Patches, 30-Pack White - Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
2018-07-16
Eversense® NOW Mobile App iOS - Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
2018-07-18
Eversense® Mobile App Android - Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
2018-07-16
Eversense® Mobile App iOS - Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
2018-07-16
Eversense® Mobile App Android - Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
2019-07-16
Eversense® Mobile App iOS - Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
2019-07-16
Eversense NOW Mobile App Android - The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
2022-01-21
Eversense DMS Pro - The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
2022-03-10
Eversense DMS - 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.
2022-03-10
Eversense® Mobile App Android - Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
2022-06-02
Eversense® Mobile App iOS - Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
2022-06-02
Eversense 365 Mobile Application (Android) - Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
2024-09-23
Eversense 365 Mobile Application (iOS) - Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
2024-09-23
Eversense 365 Adhesive Patches Kit - Eversense adhesive patches have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. The Eversense 365 kit contains 300 white patches and 90 clear patches.
2024-09-23
Eversense Adhesive Patches, 10-pack White - Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
2022-03-10
Eversense® Adhesive Patches, 30-Pack Clear - Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
2018-07-16
Eversense 365 Sensor Kit (Provider Purchase) - Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder.
2024-09-23
Eversense 365 Sensor Kit (Retail) - Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder.
2024-09-23
Eversense 365 Sensor Kit (DME) - Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder.
2024-09-23
Eversense 365 Smart Transmitter Kit (Provider Purchase) - Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
2024-09-23