BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Epredia E1000 Dx Digital Pathology Solution

    Reg #: 3003584784 · FEI: 3003584784 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SHANDON DIAGNOSTICS LIMITED
    Registration Number
    3003584784
    FEI Number
    3003584784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TUDOR ROAD, MANOR PARK
    City
    RUNCORN Cheshire East
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K241717

    Owner / Operator

    Firm Name
    Epredia Holdings Ltd.
    Operator Number
    10062642
    Address
    20 Post Road
    City
    Portsmouth
    State
    NH
    Postal Code
    03801
    Country
    US

    US Agent

    Business Name
    new erie scientific llc
    Contact Name
    Naveen Kaki
    Address
    20 post rd
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    857 2631783

    Products

    Device Name Product Code
    Digital Pathology Display PZZ
    Whole Slide Imaging System PSY
    Digital Pathology Image Viewing And Management Software QKQ

    Proprietary Names

    Epredia E1000 Dx Digital Pathology Solution

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198