BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CAPIOX SP Pump (With or Without X-Coating)

    Reg #: 8010026 · FEI: 2828 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TERUMO CORP.
    Registration Number
    8010026
    FEI Number
    2828
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    44-1, 2-CHOME, HATAGAYA
    City
    SHIBUYA-KU, TOKYO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K080774

    Owner / Operator

    Firm Name
    TERUMO CORP.
    Operator Number
    8010026
    Address
    44-1, 2-CHOME, HATAGAYA, --
    City
    SHIBUYA-KU, TOKYO
    State
    JP-NOTA
    Postal Code
    151-0072
    Country
    JP

    US Agent

    Business Name
    Terumo Medical Corp
    Contact Name
    Dina Justice
    Address
    950 Elkton Blvd.
    City
    Elkton
    State
    MD
    ZIP
    21921
    Country
    US
    Email
    [email protected]
    Phone
    410 3927226

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM

    Proprietary Names

    CAPIOX SP Pump (With or Without X-Coating)

    Establishment Types

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