BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEsay for Astigmatism with NaturMoist

    Reg #: 3008272400 · FEI: 3008272400 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OPTIC DE OCEAN PTE LTD
    Registration Number
    3008272400
    FEI Number
    3008272400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    80,GENTING LANE,GENTING BLOCK, #04-05,RUBY INDUSTRIAL COMPLEX
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K151918

    Owner / Operator

    Firm Name
    OPTIC DE OCEAN PTE LTD
    Operator Number
    10052432
    Address
    80,GENTING LANE,GENTING BLOCK, #04-05,RUBY INDUSTRIAL COMPLEX
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    34956
    Country
    SG

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEsay for Astigmatism with NaturMoist

    Establishment Types

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