BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Uriscan S-300

    Reg #: 9710094 · FEI: 3003347234 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    YD DIAGNOSTICS
    Registration Number
    9710094
    FEI Number
    3003347234
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    76, Seori-ro, Idong-eup, Cheoin-gu
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K980047

    Owner / Operator

    Firm Name
    YD DIAGNOSTICS
    Operator Number
    9044716
    Address
    76, Seori-ro, Idong-myeon, Cheoin-gu
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    17127
    Country
    KR

    US Agent

    Business Name
    Biosys Laboratories, Inc.
    Contact Name
    Jerri Pih (Hoi) Jerri Hoi
    Address
    526 Mission Street South Pasadena
    City
    S Pasadena
    State
    CA
    ZIP
    91030
    Country
    US
    Email
    [email protected]
    Phone
    626 4036565

    Products

    Device Name Product Code
    Automated Urinalysis System KQO
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Test, Urine Leukocyte LJX

    Proprietary Names

    Uriscan S-300

    Establishment Types

    Manufacture Medical Device