BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NIPRO CORPORATION

    Reg #: 3000247873 · FEI: 3000247873 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    23

    Registration Details

    Registration Name
    NIPRO CORPORATION
    Registration Number
    3000247873
    FEI Number
    3000247873
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-26, Senriokashinmachi
    City
    Settsu Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K973620

    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
    Needle, Dental DZM
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Needle, Ophthalmic Suturing HNM
    Set, Administration, Intravascular FPA
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Polymer Patient Examination Glove LZA
    Syringe, Piston FMF
    Wire, Guide, Catheter DQX
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Protector, Transducer, Dialysis FIB
    Needle, Fistula FIE
    Catheter, Hemodialysis, Non-Implanted MPB
    Accessories, Blood Circuit, Hemodialysis KOC
    System, Blood, Extracorporeal And Accessories LLB
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Needle, Aspiration And Injection, Disposable GAA
    Catheter, Retention Type, Balloon EZL
    Container, Specimen, Sterile FMH
    System, Blood Collection, Vacuum-Assisted, Manual KST

    Proprietary Names

    NIPRO Cellentia Dialyzer Ophthalmic Needle Dental Needle Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set Nipro SafeTouch Safety BCS ELISIO-09H and 25H. Nipro Scalp Vein Set Sniper Hydrophilic Guidewire AQUALiner Nipro Hydrophilic Guidewire NIPRO HYDROPHILIC FOR UR NIPRO Transducer Protector TP-SURE Nipro SafeTouch II Gamma ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M. Safe Touch PSV Winged Infusion Set (with or without filter) Surdial DX Hemodialysis System and Accessories Nipro blood tubing set Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set Nipro SafeTouch TULIP Safety AVF Needle NIPRO BioHole Needle with CAPICK Scab Remover NIPRO SAFELET CATH Nipro Hypodermic Needle NIPRO SAFETOUCH IV CATHETER winged NIPRO SAFETOUCH IV CATHETER Nipro SafeTouch II Safety AVF Syringe, Piston Nipro Blood Collection Needle

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device