BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    waist support: SGKB009, Back Support

    Reg #: 3026199641 · FEI: 3026199641 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OXYGEN RESEARCH INSTITUTE LIMITED
    Registration Number
    3026199641
    FEI Number
    3026199641
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Loughwell, Moycullen
    City
    Galway
    Country
    IE

    Owner / Operator

    Firm Name
    Oxygen Research Institute Limited
    Operator Number
    10087852
    Address
    Loughwell, Moycullen
    City
    Galway
    State
    IE-G
    Postal Code
    H91 H4C1
    Country
    IE
    Correspondent
    Patrick McKeown

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Band Or Belt, Pelvic Support ISR

    Proprietary Names

    waist support: SGKB009, Back Support

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device