BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    TAPASZTO OPTIC LTD.

    Reg #: 3002296055 · FEI: 3002296055 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    TAPASZTO OPTIC LTD.
    Registration Number
    3002296055
    FEI Number
    3002296055
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Csanyi J. krt. 8.
    City
    Kecskemet Bacs-Kiskun
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K061948
    PMA Number
    P180035

    Owner / Operator

    Firm Name
    Tapaszto Optic Ltd.
    Operator Number
    10051370
    Address
    Csanyi J. krt. 8.
    City
    Kecskemet
    State
    Bacs-Kiskun
    Postal Code
    6000
    Country
    HU
    Correspondent
    Zsolt G Tapaszto Optom., F.A.A.O.

    US Agent

    Business Name
    Z-Distribution Inc.
    Contact Name
    Zsolt Tapaszto Optom., F.A.A.O.
    Address
    621 NW 53rd Street, Suite125
    City
    Boca Raton
    State
    FL
    ZIP
    33487
    Country
    US
    Email
    [email protected]
    Phone
    408 6943860

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN
    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia QIT
    Lenses, Soft Contact, Extended Wear LPM
    Set, Administration, Intravascular FPA

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device