BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TERUMO CORP.

    Reg #: 8010026 · FEI: 2828 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    99
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    TERUMO CORP.
    Registration Number
    8010026
    FEI Number
    2828
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    44-1, 2-CHOME, HATAGAYA
    City
    SHIBUYA-KU, TOKYO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K161546
    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
    Catheter, Percutaneous DQY
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Catheter, Ultrasound, Intravascular OBJ
    Catheter, Intravascular, Diagnostic DQO
    Wire, Guide, Catheter DQX
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Stent, Superficial Femoral Artery NIP
    Laparoscope, General & Plastic Surgery GCJ
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Oxygenator, Cardiopulmonary Bypass DTZ
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Catheter, Continuous Flush KRA
    Introducer, Catheter DYB
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Clamp, Vascular DXC
    Continuous Measurement Thermometer FLL
    Supplies, Blood-Bank KSS
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    Set, Transfer (Blood/Plasma) KSB
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Detector, Bubble, Cardiopulmonary Bypass KRL
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Catheter, Urological KOD
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Set, Administration, Intravascular FPA

    Proprietary Names

    R2P SlenGuide CAPIOX® AF125X Arterial Filter DualView Catheter Glidewire GT Guide Wire M and Tapered Glidewire Gold Radifocus Guide Wire 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 MISAGO RX Self-expanding Peripheral Stent Heartrail III 5Fr Guiding Catheter Glidewire Radifocus Guide Wire for laparoscopic use Ryurei Heartrail III Coronary Guiding Catheter Radifocus Glidecath Radifocus Glidewire Radifocus Glidecath Hydrophilic Coated Catheter CHAPERON GUIDING CATHETER TRAXCESS 014" HYDROPHILIC GUIDEWIRE TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE CAPIOX® RX15 Hollow Fiber Oxygenator w/without Hardshell Reservoir R2P Radifocus Glidewire Advantage Glidewire Gold Neuro Neuro Glidewires Headliner Hydrophilic Coated Guidewire CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Terumo Hollow Fiber Oxygenator Circuit CAPIOX Cardioplegia Progreat Progreat Coaxial Microcatheter System CAPIOX Arterial Filter CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell TRAXCESS DOCKING WIRE with Integrated Arterial Filter CAPIOX FX05 Hollow Fiber Oxygenator Glidewire Gold Obturator Glidesheath CAPIOX SP Pump (With or Without X-Coating) Radifocus Torque Device Capiox SP Pump Runthrough NS Extension Wire Glidewire GT-R FineCross M3 CAPIOX FX Hollow Fiber Oxygenator 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 Radifocus Glidewire Advantage Immucise Intradermal Injection System NaviCross 018" TR Band Runthrough NS PTCA Guide Wire CAPIOX Luer Thermistor Wire Red Cable (ME Center) CAPIOX Luer Thermistor CAPIOX Luer Thermistor Wire Blue Cable (ME Center) Terumo Sampling Site Coupler Radifocus Glidewire Advantage 014 Glidewire Gold Neuro Finecross MG Coronary Micro-Guide Catheter Radifocus Optitorque Angiographic Catheter Optitorque Radifocus Glidewire Advantage Track CAPIOX FX15 and FX25 Hollow Fiber Oxygenator/Reservoir with Integrated Arterial Filter (with X-Coating) Teruflex Dry Collection Bag Tubing Clip Slide Clamp CAPIOX RX05 Hollow Fiber Oxygenator/Reservoir (with X-Coating) Terumo NaviCross Support Catheter Terumo Sterile Tubing Welder (TSCD) TSCD Wafers Teruflex Terumo Transfer Bags CAPIOX® Cardiotomy Reservoir CAPIOX Bubble Trap CAPIOX SP Pump Head Radifocus® Optitorque™ Angiographic Catheter Surflash I.V. Catheter Surflash IV Catheter TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Radifocus Guide Wire M CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating) Venoject Luer Adaptor Venoject Luer Adapter Surflo Winged Infusion Set

    Establishment Types

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