BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    PillSense Capsule

    Reg #: 3027502350 · FEI: 3027502350 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENTERASENSE LIMITED
    Registration Number
    3027502350
    FEI Number
    3027502350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block 4 Ballybrit Business Park
    City
    Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    DEN220065

    Owner / Operator

    Firm Name
    EnteraSense Limited
    Operator Number
    10088270
    Address
    Block 4 Ballybrit Business Park
    City
    Galway
    State
    IE-G
    Postal Code
    H91 A4XW
    Country
    IE
    Correspondent
    David Collins

    US Agent

    Business Name
    Freyr Inc
    Contact Name
    Shilpa Gampa
    Address
    150 College Rd W Ste 102
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    760 5834401

    Products

    Device Name Product Code
    Blood Detection Capsule QUD

    Proprietary Names

    PillSense Capsule PillSense Receiver

    Establishment Types

    Manufacture Medical Device