BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay)

    Reg #: 3014053517 · FEI: 3014053517 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BONRAYBIO CO., LTD.
    Registration Number
    3014053517
    FEI Number
    3014053517
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F., No. 118, Gongye 9th Rd., Dali Dist.
    City
    Taichung
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K242388

    Owner / Operator

    Firm Name
    Bonraybio Co., LTD.
    Operator Number
    10055998
    Address
    4F., No. 118, Gongye 9th Rd., Dali Dist.
    City
    Taichung
    State
    TW-TXG
    Postal Code
    41280
    Country
    TW

    US Agent

    Business Name
    Dynamic Biotech Inc.
    Contact Name
    Feng-Yu Lee
    Address
    29122 Rancho Viejo Rd., Suite 212
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US
    Email
    [email protected]
    Phone
    949 2180929

    Products

    Device Name Product Code
    Semen Analysis Device POV

    Proprietary Names

    LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay) LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) LensHooke X12 PRO Semen Analysis System; LensHooke CS3 10?m Semen Test Slide

    Establishment Types

    Manufacture Medical Device