BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Viberect

    Reg #: 3028192422 · FEI: 3028192422 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIJIWORKS TASARIM VE URUN GELISTIRME SANAYI TICARET LIMITED SIRKETI
    Registration Number
    3028192422
    FEI Number
    3028192422
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EVKA 3 mah. 4. San. Sit. 129/21 sokak no 10/B
    City
    Bornova Izmir
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K110566

    Owner / Operator

    Firm Name
    NIJIWORKS TASARIM VE URUN GELISTIRME SANAYI TICARET LIMITED
    Operator Number
    10090270
    Address
    EVKA 3 mah. 4. San. Sit. 129/21 sokak no 10/B
    City
    Bornova
    State
    Izmir
    Postal Code
    35050
    Country
    TR
    Correspondent
    Ates Gokdemir

    US Agent

    Business Name
    Reflexonic LLC
    Contact Name
    Kambiz Tajkarimi
    Address
    44055 riverside pkwy, suite 208
    City
    Leesburg
    State
    VA
    ZIP
    20176
    Country
    US
    Email
    [email protected]
    Phone
    202 3218162

    Products

    Device Name Product Code
    Vibrator For Therapeutic Use, Genital KXQ

    Proprietary Names

    Viberect Ferticare 2 Viberect Pro

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)