BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NIPRO CORPORATION ODATE FACTORY

    Reg #: 9610987 · FEI: 3002807710 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    NIPRO CORPORATION ODATE FACTORY
    Registration Number
    9610987
    FEI Number
    3002807710
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8-7, Hanukiyachi, Niida
    City
    ODATE-SHI Akita
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160444

    Owner / Operator

    Firm Name
    NIPRO CORPORATION
    Operator Number
    8030375
    Address
    3-26, Senriokashinmachi
    City
    Settsu
    State
    Osaka
    Postal Code
    566-8510
    Country
    JP
    Correspondent
    Nobuhiro Morimoto

    US Agent

    Business Name
    NIPRO MEDICAL CORPORATION
    Contact Name
    JESSICA OSWALD-MCLEOD
    Address
    3150 NW 107th Ave
    City
    Doral
    State
    FL
    ZIP
    33172
    Country
    US
    Email
    [email protected]
    Phone
    305 4326699

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Immunoassay Method, Troponin Subunit MMI
    Fluorometric Method, Cpk Or Isoenzymes JHX
    Myoglobin, Antigen, Antiserum, Control DDR
    Calibrator, Secondary JIT
    Fibrin Split Products GHH
    Test, Natriuretic Peptide NBC
    System, Test, C-Reactive Protein DCN
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    NIPRO Cellentia Dialyzer Surdial DX Hemodialysis System and Accessories ELISIO-09H and 25H. ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M. NIPRO SAFELET CATH

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)