BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    BioHealx Anal Fistula Device

    Reg #: 3008889904 · FEI: 3008889904 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SCHIVO
    Registration Number
    3008889904
    FEI Number
    3008889904
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Units 1 - 4 IDA Business Park, Cork Road
    City
    Waterford Waterford (City and County)
    Country
    IE

    Regulatory Submissions

    510(k) Number
    DEN240007

    Owner / Operator

    Firm Name
    Schivo
    Operator Number
    10084071
    Address
    Units 1 - 4 IDA Business Park, Cork Road
    City
    Waterford
    State
    Waterford (City and County)
    Postal Code
    X91RP79
    Country
    IE

    US Agent

    Business Name
    Schivo
    Contact Name
    Nicole Needle
    Address
    1 Commercial Ct
    City
    Plainview
    State
    NY
    ZIP
    11803
    Country
    US
    Email
    [email protected]
    Phone
    516 7194146 ext. 244

    Products

    Device Name Product Code
    Anal Fistula Closure Device QML

    Proprietary Names

    BioHealx Anal Fistula Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)