BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    ROCKFIELD MEDICAL DEVICES LTD.

    Reg #: 3017607339 · FEI: 3017607339 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ROCKFIELD MEDICAL DEVICES LTD.
    Registration Number
    3017607339
    FEI Number
    3017607339
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ATU iHub Galway, Old Dublin Road
    City
    Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K233034

    Owner / Operator

    Firm Name
    Rockfield Medical Devices Ltd
    Operator Number
    10087042
    Address
    ATU iHub Galway, Old Dublin Road
    City
    Galway
    State
    IE-G
    Postal Code
    H91 DCH9
    Country
    IE
    Correspondent
    Orla Connaughton

    US Agent

    Business Name
    Vista Regulatory Solutions LLC
    Contact Name
    Tom Dold
    Address
    18025 E. Sioux Vista Drive Jordan MN 55352 USA, Jordan
    City
    Jordan
    State
    MN
    ZIP
    55352
    Country
    US
    Email
    [email protected]
    Phone
    612 9656057

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Garment, Storage, Peritoneal Dialysis Catheter OAG

    Proprietary Names

    Mobility+ Enteral Feeding System OTC Mobility+ Enteral Feeding System Mobility+ Bag

    Establishment Types

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