BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Reservoir

    Reg #: 9681834 · FEI: 3002808327 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASHITAKA FACTORY OF TERUMO CORP.
    Registration Number
    9681834
    FEI Number
    3002808327
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 MAIMAIGI-CHO
    City
    FUJINOMIYA Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K051997

    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
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    Reservoir CAPIOX® RX15 Hollow Fiber Oxygenator w/without Hardshell

    Establishment Types

    Manufacture Medical Device