BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Affinity CP Pump with Balance Coating

    Reg #: 3012119238 · FEI: 3012119238 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KYOCERA Corporation Shiga Yasu Plant
    Registration Number
    3012119238
    FEI Number
    3012119238
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    800 Ichimiyake
    City
    Yasu-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K111657

    Owner / Operator

    Firm Name
    KYOCERA Corporation
    Operator Number
    9097359
    Address
    6 Takeda Tobadono-cho, Fushimi-ku, --
    City
    Kyoto
    State
    JP-NOTA
    Postal Code
    612-8501
    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

    Proprietary Names

    Affinity CP Pump with Balance Coating

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)