BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    System, image management, ophthalmic

    Reg #: 9616199 · FEI: 3003768492 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HUVITZ CO., LTD.
    Registration Number
    9616199
    FEI Number
    3003768492
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    38, Burim-ro 170beon-gil, Dongan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K191615

    Owner / Operator

    Firm Name
    HUVITZ CO., LTD.
    Operator Number
    9039310
    Address
    38, Burim-ro 170beon-gil, Dongan-gu
    City
    Anyang-si
    State
    Gyeonggi
    Postal Code
    14055
    Country
    KR
    Correspondent
    Hyung Min Heo

    US Agent

    Business Name
    Coburn Technologies
    Contact Name
    Dayna Valente
    Address
    83 Gerber Rd. W
    City
    South Windsor
    State
    CT
    ZIP
    06074
    Country
    US
    Email
    [email protected]
    Phone
    860 6484906

    Products

    Device Name Product Code
    System, Image Management, Ophthalmic NFJ

    Proprietary Names

    System, image management, ophthalmic HIS-5000U( (10M, 5M, 1.4M)

    Establishment Types

    Manufacture Medical Device