BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Stellar Hypoallergenic Filter

    Reg #: 3004428458 · FEI: 3004428458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GVS Filter Technology UK Ltd
    Registration Number
    3004428458
    FEI Number
    3004428458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NFC HOUSE, MELLISHAW LANE
    City
    MORECAMBE Lancashire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K122715

    Owner / Operator

    Firm Name
    GVS Filter Technology UK Ltd.
    Operator Number
    9098065
    Address
    NFC HOUSE, MELLISHAW LANE
    City
    MORECAMBE, LANCS
    State
    GB-NOTA
    Postal Code
    LA3 3EN
    Country
    GB

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT

    Proprietary Names

    Stellar Hypoallergenic Filter 7274/422APUA008/0006 R241-7019

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)