Senseonics, Inc.

FDA Device Registration & Listing · Germantown, MD, US · Registration 3009862700

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009862700
FEI Number
3009862700
Entity Name
Senseonics, Inc.
City/State/Country
Germantown, MD, US
Establishment Address
20451 Seneca Meadows Pkwy, Germantown, MD 20876, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Senseonics, Inc. (Owner Number: 10044307)
Owner / Operator Contact Address
20451 Seneca Meadows Parkway, Germantown, MD 20876, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Eversense NOW Application Eversense 365 Continuous Glucose Monitoring (CGM) System Eversense Data Management System (DMS and DMS Pro)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PJT Continuous Glucose Monitor Secondary Display Clinical Chemistry Class 2 862.1350 2018-07-03
SBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate Clinical Chemistry Class 2 862.1357 2024-09-18
PHV Continuous Glucose Monitor Retrospective Data Analysis Software Clinical Chemistry Class 1 862.2120 2018-07-03

Official Correspondent

Mukul Jain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Senseonics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009862700. Last updated year: 2026. Please use registration number 3009862700 when referencing this establishment in official correspondence.
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