BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    ENTERASENSE LIMITED

    Reg #: 3027502350 · FEI: 3027502350 · Expires 2026
    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
    2026
    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
    Aoife McKeon

    US Agent

    Business Name
    FREYR INC
    Contact Name
    Shilpa Gampa
    Address
    777 Scudders Mill Road, Building 2, Suite 150
    City
    Plainsboro
    State
    NJ
    ZIP
    08536
    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