BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KYOCERA Medical Corporation Shiga Yasu Plant

    Reg #: 3012119238 · FEI: 3012119238 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    KYOCERA Medical Corporation Shiga Yasu Plant
    Registration Number
    3012119238
    FEI Number
    3012119238
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    800 Ichimiyake
    City
    Yasu-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160895

    Owner / Operator

    Firm Name
    KYOCERA Medical Corporation
    Operator Number
    9097359
    Address
    6 Takeda Tobadono-cho, Fushimi-ku, --
    City
    Kyoto
    State
    JP-NOTA
    Postal Code
    612-8450
    Country
    JP
    Correspondent
    Masato - Atsumi

    US Agent

    Business Name
    Hastings Regulatory Consulting, LLC
    Contact Name
    Cheryl Hastings
    Address
    2256 E Blossom Lane
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    574 5274220

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA

    Proprietary Names

    AFFINITY CP CENTRIFUGAL BLOOD PUMP DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads Affinity CP Pump with Carmeda Coating Affinity CP Pump with Balance Coating

    Establishment Types

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