BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    iVue

    Reg #: 3010000450 · FEI: 3010000450 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CRYSTALVUE MEDICAL CORPORATION
    Registration Number
    3010000450
    FEI Number
    3010000450
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.116, Ln.956, Zhongshan Rd.,
    City
    Taoyuan Dist.,
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K163475

    Owner / Operator

    Firm Name
    CRYSTALVUE MEDICAL CORPORATION
    Operator Number
    10045401
    Address
    No.116, Ln.956, Zhongshan Rd.,
    City
    Taoyuan Dist.,
    State
    TW-TAO
    Postal Code
    330
    Country
    TW
    Correspondent
    Beth Wang

    US Agent

    Business Name
    Harvest & Victory Consulting Corp. (USA)
    Contact Name
    Jennifer Reich
    Address
    2904 N. Boldt Drive
    City
    Flagstaff
    State
    AZ
    ZIP
    86001
    Country
    US
    Email
    [email protected]
    Phone
    928 8638410

    Products

    Device Name Product Code
    Ophthalmoscope, Ac-Powered HLI
    Tomography, Optical Coherence OBO

    Proprietary Names

    iVue

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)