BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    PT. Nipro Indonesia Jaya

    Reg #: 3010377171 · FEI: 3010377171 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    PT. Nipro Indonesia Jaya
    Registration Number
    3010377171
    FEI Number
    3010377171
    Status
    Active
    Expiry Year
    2026
    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
    K191359

    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
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    Nipro Syringe Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set Surdial DX Hemodialysis System and Accessories Nipro blood tubing set Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set

    Establishment Types

    Manufacture Medical Device