BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    Surdial DX Hemodialysis System and Accessories

    Reg #: 3010377171 · FEI: 3010377171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PT. Nipro Indonesia Jaya
    Registration Number
    3010377171
    FEI Number
    3010377171
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kawasan Industri Suryacipta, Jl. Surya Utama Kav. I 22B, 23 & 24, Desa Kutamekar, Kec. Ciampel
    City
    Karawang Jawa Barat
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K182940

    Owner / Operator

    Firm Name
    NIPRO CORPORATION
    Operator Number
    8030375
    Address
    3-26, Senriokashinmachi, Settsu,, --
    City
    Osaka
    State
    JP-27
    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

    Proprietary Names

    Surdial DX Hemodialysis System and Accessories

    Establishment Types

    Manufacture Medical Device