BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    OPHTEC BV

    Reg #: 8040449 · FEI: 3002501070 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    OPHTEC BV
    Registration Number
    8040449
    FEI Number
    3002501070
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SCHWEITZERLAAN 15
    City
    GRONINGEN
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K030471
    PMA Number
    P030028

    Owner / Operator

    Firm Name
    OPHTEC USA
    Operator Number
    8040449
    Address
    400 sawgrass corporate pkwy
    City
    Sunrise
    State
    FL
    Postal Code
    33325
    Country
    US
    Correspondent
    William Rosero

    Products

    Device Name Product Code
    Lens, Intraocular, Phakic MTA
    Forceps, Ophthalmic HNR
    Hook, Ophthalmic HNQ
    Ring, Endocapsular MRJ

    Proprietary Names

    Artiflex Myopia Phakic Lens Veriflex Myopia Phakic Lens Verisyse Myopia Phakic Lens Artisan Myopia Phakic Lens ARTISAN Enclavation Forceps Artifix Holding Forceps ARTISAN Implantation Forceps Artisan - Artiflex Enclavation Needle Verisyse - Veriflex Enclavation Needle RingJect StabilEyes Capsular Tension Ring Ophtec Capsular Tension Ring ARTISAN Lens Manipulator

    Establishment Types

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