BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HPLC instrument for Variant II Hemoglobin System

    Reg #: 1000487132 · FEI: 1000487132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OEM SYSTEMS CO. LTD.
    Registration Number
    1000487132
    FEI Number
    1000487132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 MEKAWA MAKISHIMA-CHO
    City
    UJI-SHI Kyoto
    Country
    JP

    Owner / Operator

    Firm Name
    OEM SYSTEMS CO. LTD.
    Operator Number
    9050895
    Address
    84 MEKAWA MAKISHIMA-CHO
    City
    UJI-SHI KYOTO
    State
    JP-NOTA
    Postal Code
    6110041
    Country
    JP
    Correspondent
    Kenneth Block

    US Agent

    Business Name
    Ken Block Consulting
    Contact Name
    Kenneth Block
    Address
    800 E Campbell Rd Suite 202
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US
    Email
    [email protected]
    Phone
    972 4809554

    Products

    Device Name Product Code
    Instrumentation, High Pressure Liquid Chromatography LDM

    Proprietary Names

    HPLC instrument for Variant II Hemoglobin System HPLC instrument for Variant Newborn Hemoglobin Screening System HPLC instrument for Variant nbs Newborn Screening System HPLC instrument for Variant II Turbo Link

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)