BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ASHITAKA FACTORY OF TERUMO CORP.

    Reg #: 9681834 · FEI: 3002808327 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    85
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    ASHITAKA FACTORY OF TERUMO CORP.
    Registration Number
    9681834
    FEI Number
    3002808327
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 MAIMAIGI-CHO
    City
    FUJINOMIYA Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K240818
    PMA Number
    P140002

    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
    Wire, Guide, Catheter DQX
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Detector, Bubble, Cardiopulmonary Bypass KRL
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Catheter, Percutaneous DQY
    Oxygenator, Cardiopulmonary Bypass DTZ
    Stent, Superficial Femoral Artery NIP
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Continuous Flush KRA
    Introducer, Catheter DYB
    Catheter, Ultrasound, Intravascular OBJ
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Urological KOD
    Clamp, Vascular DXC
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Laparoscope, General & Plastic Surgery GCJ
    Continuous Measurement Thermometer FLL
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Endoscopic Guidewire, Gastroenterology-Urology OCY

    Proprietary Names

    R2P Radifocus Glidewire Advantage CAPIOX® AF125X Arterial Filter CAPIOX Bubble Trap Guide Wire M and Tapered Glidewire Gold Radifocus Guide Wire CAPIOX SP Pump (With or Without X-Coating) R2P SlenGuide Radifocus Glidewire Advantage 014 CHAPERON GUIDING CATHETER NaviCross 018" Runthrough NS Extension Wire CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir MISAGO RX Self-expanding Peripheral Stent Radifocus Glidecath Hydrophilic Coated Catheter Radifocus Torque Device TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Glidewire Gold Neuro Neuro Glidewires Headliner Hydrophilic Coated Guidewire Finecross MG Coronary Micro-Guide Catheter Obturator Glidesheath CAPIOX FX15 and FX25 Hollow Fiber Oxygenator/Reservoir with Integrated Arterial Filter (with X-Coating) Heartrail III 5Fr Guiding Catheter Heartrail III Coronary Guiding Catheter Radifocus Glidewire CAPIOX Arterial Filter Terumo Hollow Fiber Oxygenator Circuit Runthrough NS PTCA Guide Wire TRAXCESS 014" HYDROPHILIC GUIDEWIRE CAPIOX® RX15 Hollow Fiber Oxygenator w/without Hardshell CAPIOX SP Pump Head Radifocus Optitorque Angiographic Catheter Progreat Progreat Coaxial Microcatheter System Terumo NaviCross Support Catheter Radifocus Glidewire Advantage TRAXCESS DOCKING WIRE DualView Catheter FineCross M3 CAPIOX RX05 Hollow Fiber Oxygenator/Reservoir (with X-Coating) with Integrated Arterial Filter CAPIOX FX05 Hollow Fiber Oxygenator Ryurei Radifocus Guide Wire M Glidewire TR Band CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating) Holder for CAPIOX® SX18 Holder for CAPIOX® SX18R CAPIOX® FX Holder CAPIOX® CR Holder Holder for CAPIOX® Sampling Manifold CAPIOX® Cardiotomy Reservoir Holder Holder for CAPIOX® Oxygenator with Reservoir Holder for CAPIOX® Filters and Bubble Traps Holder for CAPIOX® Oxygenator Holder for CAPIOX® RX/FX 15 & 25 Oxygenators CAPIOX FX Hollow Fiber Oxygenator Capiox SP Pump Glidewire Gold Neuro Radifocus Glidewire Advantage Track Glidewire GT-R Radifocus Guide Wire for laparoscopic use Glidewire GT CAPIOX Luer Thermistor Wire Red Cable (ME Center) CAPIOX Luer Thermistor CAPIOX Luer Thermistor Wire Blue Cable (ME Center) Optitorque CAPIOX® Cardiotomy Reservoir CAPIOX Cardioplegia Radifocus Glidecath Radifocus® Optitorque™ Angiographic Catheter G-240-3527S G-240-3545A VisiGlide Single Use Guidewire G-240-2527A G-240-3545S G-240-2545S Radifocus Glidewire® Endoscopic Wire G-240-3527A Single Use Guidewire G-240-2527S G-240-2545A Glidewire Gold

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility