BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    BioHealx Anal Fistula Device

    Reg #: 3015615781 · FEI: 3015615781 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SIGNUM SURGICAL LIMITED
    Registration Number
    3015615781
    FEI Number
    3015615781
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Signum Surgical Limited, New Docks, Port of Galway
    City
    Galway Galway (City)
    Country
    IE

    Regulatory Submissions

    510(k) Number
    DEN240007

    Owner / Operator

    Firm Name
    Signum Surgical Limited
    Operator Number
    10092825
    Address
    Signum Surgical Limited, New Docks, Port of Galway
    City
    Galway
    State
    Galway (City)
    Postal Code
    H91NNY6
    Country
    IE
    Correspondent
    Moshe Zilversmit

    US Agent

    Business Name
    Signum Surgical USA Inc.
    Contact Name
    Carol Burns
    Address
    175 Strafford Ave Ste 1
    City
    Wayne
    State
    PA
    ZIP
    19087
    Country
    US
    Email
    [email protected]
    Phone
    610 8606577

    Products

    Device Name Product Code
    Anal Fistula Closure Device QML

    Proprietary Names

    BioHealx Anal Fistula Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device