BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    OPTIKAL (SOUTHGATE) LTD

    Reg #: 3044710860 · FEI: 3044710860 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    OPTIKAL (SOUTHGATE) LTD
    Registration Number
    3044710860
    FEI Number
    3044710860
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21 BULLHEAD ROAD
    City
    BOREHAMWOOD
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K123994

    Owner / Operator

    Firm Name
    OPTIKAL (SOUTHGATE) LTD
    Operator Number
    10095708
    Address
    21 BULLHEAD ROAD
    City
    BOREHAMWOOD
    State
    GB-NOTA
    Postal Code
    WD6 1HW
    Country
    GB

    US Agent

    Business Name
    Liberty Management Group Ltd.
    Contact Name
    MANOJ ZACHARIAS
    Address
    75 Executive Drive, Suite 114,
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

    Device Name Product Code
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Dailies AquaComfort Plus Toric 30pk Dailies AquaComfort Plus Multifocal 30pk Dailies AquaComfort Plus 30pk Dailies AquaComfort Plus Multifocal 90pk Dailies AquaComfort Plus 90pk Dailies AquaComfort Plus Toric 90pk Acuvue 2 Dailies Total1 for Astigmatism 30pk Dailies Total1 Multifocal 90pk Dailies Total1 Multifocal 30pk Dailies Total1 90pk Dailies Total1 6pk Dailies Total1 30pk Precision1 for Astigmatism 90pk Precision1 90pk Precision1 for Astigmatism 30pk Precision1 30pk Acuvue Oasys 1-Day for Astigmatism 90pk Acuvue Oasys 1-Day 30pk Acuvue Oasys Multifocal 6pk Acuvue Oasys Max 30pk Acuvue Oasys 24pk Acuvue Oasys 1-Day 90pk Acuvue Oasys 12pk Acuvue Oasys Max Multifocal 30pk Acuvue Oasys 1-Day for Astigmatism 30pk Acuvue Oasys for Astigmatism 6pk Acuvue Oasys Max Multifocal 90pk Acuvue Oasys 6pk Acuvue Oasys Max 90pk Acuvue Vita 6pk Acuvue Vita for Astigmatism 6pk Acuvue Moist 30pk Acuvue Moist for Astigmatism 30pk Acuvue Moist Multifocal 30pk Acuvue Moist Multifocal 90pk Acuvue Moist for Astigmatism 90pk Acuvue Moist 90pk

    Establishment Types

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