BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Eversense 365 Continuous Glucose Monitoring (CGM) System

    Reg #: 3009862700 · FEI: 3009862700 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Senseonics, Inc.
    Registration Number
    3009862700
    FEI Number
    3009862700
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20451 Seneca Meadows Pkwy
    City
    Germantown
    State
    MD
    ZIP
    20876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241335

    Owner / Operator

    Firm Name
    Senseonics, Inc.
    Operator Number
    10044307
    Address
    20451 Seneca Meadows Parkway
    City
    Germantown
    State
    MD
    Postal Code
    20876
    Country
    US
    Correspondent
    Mukul Jain

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate SBA

    Proprietary Names

    Eversense 365 Continuous Glucose Monitoring (CGM) System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility