BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LensHooke X1 Semen Quality Analyzer

    Reg #: 3016090200 · FEI: 3016090200 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BONRAYBIO USA CORPORATION
    Registration Number
    3016090200
    FEI Number
    3016090200
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 VALLEY VISTA DR STE 207
    City
    Diamond Bar
    State
    CA
    ZIP
    91765
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180343

    Owner / Operator

    Firm Name
    BONRAYBIO USA CORPORATION
    Operator Number
    10061873
    Address
    1300 VALLEY VISTA DR STE 207
    City
    Diamond Bar
    State
    CA
    Postal Code
    91765
    Country
    US
    Correspondent
    Cheng-Teng Hsu

    Products

    Device Name Product Code
    Semen Analysis Device POV
    Counter, Differential Cell GKZ

    Proprietary Names

    LensHooke X1 Semen Quality Analyzer LensHooke X1 PRO Semen Quality Analyzer LensHooke Semen Test Cassette

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198