BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Kaneka Corporation Osaka Plant

    Reg #: 9614654 · FEI: 3002808904 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    Kaneka Corporation Osaka Plant
    Registration Number
    9614654
    FEI Number
    3002808904
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5-1-1, Torikai-nishi,
    City
    Settsu-shi Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170941
    PMA Number
    P910018

    Owner / Operator

    Firm Name
    KANEKA CORP.
    Operator Number
    9005249
    Address
    2-3-18, Nakanoshima, Kita-ku
    City
    Osaka
    State
    JP-27
    Postal Code
    530-8288
    Country
    JP

    US Agent

    Business Name
    Kaneka Medical America LLC
    Contact Name
    Audra bogucki
    Address
    623 FIFTH AVE.,
    City
    NEW YORK
    State
    NY
    ZIP
    10022
    Country
    US
    Email
    [email protected]
    Phone
    917 6289870

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Lipoprotein, Low Density, Removal MMY
    Beta 2-Microglobulin Apheresis Column PDI
    Catheter, Percutaneous DQY
    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma MDP
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients PBN
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG
    Lacrimal Stents And Intubation Sets OKS

    Proprietary Names

    RX NC Takeru Liposorber LA-15 system Lixelle ?2-microglobulin Apheresis Column Metacross RX Plasmaflo OP-05W(A) Metacross OTW Crosstella OTW RX Takeru Liposorber LA-15 System Crosstella RX R2P Crosstella RX R2P Metacross RX Crosperio OTW EDG v4 i-ED COIL Lacriflow CL OTW Takeru Crosperio RX

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility