BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Creagh Medical Ltd.

    Reg #: 3005994106 · FEI: 3005994106 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Creagh Medical Ltd.
    Registration Number
    3005994106
    FEI Number
    3005994106
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IDA Business Park, Ballinasloe
    City
    Co. Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K242419

    Owner / Operator

    Firm Name
    Surmodics, Inc
    Operator Number
    10023361
    Address
    9924 W 74th street
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US

    US Agent

    Business Name
    Surmodics
    Contact Name
    Carla Erickson
    Address
    9924 West 74th Street
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    952 5007258

    Products

    Device Name Product Code
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Introducer, Catheter DYB
    Catheter, Intravascular Occluding, Temporary MJN

    Proprietary Names

    Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter Sublime 014 Rx PTA Catheter Passeo-35 HP PTA Balloon Dilatation Catheter FirstChoice™ Ultra High Pressure PTA Balloon Catheters Advance Serenity® 14 Hydrophilic PTA Balloon Dilatation Catheter SurVeil Drug-Coated Balloon Sublime Radial Access Guide Sheath GORE Molding and Occlusion Balloon (MOB) Catheter Telemark Microcatheter Sublime Radial Access 018 PTA Balloon Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)