BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    RAYENCE CO., LTD.

    Reg #: 3009048384 · FEI: 3009048384 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    RAYENCE CO., LTD.
    Registration Number
    3009048384
    FEI Number
    3009048384
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240371

    Owner / Operator

    Firm Name
    Rayence Co., Ltd.
    Operator Number
    10036755
    Address
    14, Samsung 1-ro 1-gil
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18449
    Country
    KR

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, X-Ray, Extraoral Source, Digital MUH
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, Image Processing, Radiological LLZ
    Bracket, Ceramic, Orthodontic NJM
    Bracket, Metal, Orthodontic EJF

    Proprietary Names

    0909FCC 0909FCC-HS GreenON 2430TCA 1717FCC 0909FCB, 1212FCA Xmaru Podview Xmaru Chiroview Xmaru PACS XmaruView V1 Xmaru Pro Vatech Clismile 1717SGV 1717SCV GALAXY-R 1417WCE-HR 1417WCE 1417WCE-HS 1417WCE-GF 1417WCC_140um 1417WCC_127um 1717WCE-GF 1717WCE 1717WCE-HR 1717WCE-HS 1212FCA ClearON Mobile ShezON

    Establishment Types

    Manufacture Medical Device