BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SKYTEC UX209

    Reg #: 3023190428 · FEI: 3023190428 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Globus (Shetland) Limited
    Registration Number
    3023190428
    FEI Number
    3023190428
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Trafford Point, T2,, Twining Rd, Trafford Park,
    City
    Manchester
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K240021

    Owner / Operator

    Firm Name
    Globus (Shetland) Ltd
    Operator Number
    10085242
    Address
    Trafford Point, T2,, Twining Rd, Trafford Park,
    City
    Manchester
    State
    GB-MAN
    Postal Code
    M17 1SH
    Country
    GB
    Correspondent
    Christian Halford

    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
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    SKYTEC UX209 SKYTEC UX409 SKYTEC UX269

    Establishment Types

    Foreign Private Label Distributor