BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Terumo Medical Canada, Inc.

    Reg #: 3008307705 · FEI: 3008307705 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    139
    Establishment Types
    1
    Classifications
    28

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    Registration Details

    Registration Name
    Terumo Medical Canada, Inc.
    Registration Number
    3008307705
    FEI Number
    3008307705
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10911 Keele Street, Units 2-4
    City
    Vaughan Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K093647
    PMA Number
    P170032

    Owner / Operator

    Firm Name
    TERUMO MEDICAL CORP.
    Operator Number
    9003933
    Address
    265 Davidson Avenue, Ste. 320
    City
    Somerset
    State
    NJ
    Postal Code
    08873
    Country
    US

    US Agent

    Business Name
    Terumo Medical Corporation
    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
    Device, Vascular, For Promoting Embolization KRD
    Syringe, Antistick MEG
    Introducer, Catheter DYB
    Needle, Hypodermic, Single Lumen FMI
    Oxygenator, Cardiopulmonary Bypass DTZ
    Device, Neurovascular Embolization HCG
    Set, Administration, Intravascular FPA
    Accessories, Catheter KGZ
    Intrasaccular Flow Disruption Device OPR
    Catheter, Intravascular, Diagnostic DQO
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Intracranial Aneurysm Flow Diverter OUT
    Catheter, Percutaneous DQY
    Syringe, Piston FMF
    Device, Hemostasis, Vascular MGB
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Continuous Measurement Thermometer FLL
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Catheter, Continuous Flush KRA
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Catheter, Urological KOD
    Detector, Bubble, Cardiopulmonary Bypass KRL
    Intracranial Coil-Assist Stent QCA
    Aspiration Thrombectomy Catheter QEZ
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Traxcess Docking Wire AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 Terumo Surguard2 with Safety Hypodermic Needle, Terumo Surguard2 Safety Syringe, Surguard2 Safety Hypodermic Needle, Terumo Surguard2 Safety Hypodermic Needle Surguard2 Safety Syringe, Surguard2 Safety Needle, Terumo Surguard2 Safety Needle, Glidesheath K-Pack Surshield Needle, Hypodermic Needle for Single Use CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER K-Pack II Needle-21G x 2 27G X 1/2 K-Pack II Needle - 29G x 5/16 Thin Wall AZUR Peripheral Hydrocoil Embolization System SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) LIPO-PORT WEB Aneurysm Embolization System Surshield Safety Winged Blood Collection Set Radifocus Glidecath, Radifocus Glidecath XP HydroFrame 18 Advanced HyperSoft 3D Advanced TREO Abdominal Stent-Graft System Azur Detachable 35 Platinum Coil System MicroPlex Cosmos Radifocus® Optitorque™ Angiographic Catheter HydroSoft 3D Advanced FRED 21 R2P NaviCross K-PACK II SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) Hypodermic Syringe Without Needle Radifocus Glidewire Advantage Angio-Seal VIP Vascular Closure Device Angio-Seal Terumo SurGuard3 Safety Hypodermic Needle CAPIOX AF125X ARTERIAL FILTER AZUR Peripheral Hydrocoil Endovascular Embolization Coil System AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 Glidewire Advantage Track Progreat TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Traxcess CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR Radifocus Introducer II with R/O Marker Pinnacle R/O II Neuro Glidewires Headliner Hydrophilic Coated Guidewire; Glidewire Gold Neuro CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR K-PACK II NEEDLE- 27G & 30G THIN WALL CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER Cosmos 10 Advanced Surflo Winged Infusion Set R2P Destination Slender Guiding Sheath HydroCoil® Embolic System (HES) MicroPlex® Coil System (MCS) Headway 17 Microcatheter CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR Glidewire GT, Glidewire Gold Radifocus Glidewire, Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath TERUMO HOLLOW OXYGENATOR CIRCUIT Radifocus Introducer II Pinnacle Introducer Sheath CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS AZUR Peripheral Hydrocoil Embolization System (Detachable 18) Glidesheath Slender HydroFill 10 Advanced Progreat Coaxial Microcatheter System Surflash IV Catheter SOFIA 6F Catheter AZUR CX Coil System-Detachable 18 AZUR CX Finecross M3 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR Heartrail III Coronary Guiding Catheter Radifocus Glidewire Radifocus Torque Device Terumo Syringe, Terumo Syringe w Needle Azur Peripheral Hydrocoil Embolization System Detachable 35 R2P™ Destination Slender™ Guiding Sheath Runthrough NS Extension Wire CAPIOX FLEXIBLE VENOUS RESERVOIR Terumo Surflo I.V. Catheter K-PACK II NEEDLE - 27G X 3/4 THIN WALL Radifocus Glidewire Advantage 014 Glidesheath Slender Tibial Pedal Kit 29G AND 30G K-PACK II NEEDLE VIA-17 MICROCATHETER,VIA-17-154-01 Pinnacle R/O II HiFlo Terumo NaviCross Support Catheter Glidewire Gold Neuro X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR Scepter Mini Occlusion Balloon Catheter RelayPro Thoracic Stent-Graft System HyperSoft Advanced AZUR CX Detachable 18 Peripheral Coil System K-PACK II NEEDLE - 29G THIN WALL Glidewire GT-R Navicross 018 Headway 27 Microcatheter Progreat Lambda MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) MicroPlex VFC Advanced CAPIOX CARDIOTOMY RESERVOIR Heartrail III 5Fr Guiding Catheter Chaperon Guiding Catheter,System Terumo®SurGuard®3 Safety Needle Terumo®SurGuard®3 Hypodermic Syringe with Safety Needle HydroFrame 10 Advanced Terumo Single Use Guidewire VisiGlide Single Use Guidewire CAPIOX HEMOCONCENTRATOR CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR AZUR CX Peripheral Coil System Detachable 35 Glidewire Radifocus Guide Wire M, CAPIOX ARTERIAL FILTER Progreat Coaxial Microcatheter System, Radifocus Glidewire® Endoscopic Wire CAPIOX(R) BUBBLE TRAP Terumo Syringe / Hypodermic Syringe w/o Needle LVIS AZUR Pushable 18 & 35 System Surshield Safety Winged Infusion Set Prevent Safety Winged Infusion Set Headway 21+ Microcatheter Glidewire GT Pinnacle Precision Access System Terumo SurGuard3 Safety Needle Terumo SurGuard Hypodermic Syringe with Safety Needle AZUR Peripheral Hydrocoil Embolization System (Detachable 35) Runthrough NS PTCA Guide Wire Radifocus Glidecath Hydrophilic Coated Catheter Priority One AC Terumo Needle, Terumo Hypodermic Needle, Hypodermic Single Lumen Needle Venoject Luer Adapter Radifocus Optitorque Angiographic Catheter

    Establishment Types

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