BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    MERIT MEDICAL IRELAND, LTD

    Reg #: 9616662 · FEI: 3000335778 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    137
    Establishment Types
    4
    Classifications
    32

    Registration Details

    Registration Name
    MERIT MEDICAL IRELAND, LTD
    Registration Number
    9616662
    FEI Number
    3000335778
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parkmore Business Park West
    City
    Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K850827

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC.
    Contact Name
    John Knorpp
    Address
    1600 WEST MERIT PKWY.
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Needle, Aspiration And Injection, Disposable GAA
    Device, Percutaneous Retrieval MMX
    Wire, Guide, Catheter DQX
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Stylet, Catheter DRB
    Syringe, Balloon Inflation, Exempt PTM
    Cement, Bone, Vertebroplasty NDN
    Wire, Guide, Catheter, Exempt PTL
    Needle, Catheter GCB
    Dispenser, Cement KIH
    Arthroscope HRX
    Catheter, Continuous Flush KRA
    Mechanical Thrombolysis Catheter QEY
    Orthopedic Manual Surgical Instrument LXH
    Bone Cement LOD
    Device, Vascular, For Promoting Embolization KRD
    Stylet, Surgical, General & Plastic Surgery GAH
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Cannula, Surgical, General & Plastic Surgery GEA
    Instrument, Manual, Surgical, General Use MDM
    Dilator, Catheter GCC
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Needle, Biopsy, Cardiovascular DWO
    Bit, Drill HTW
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Instruments, Surgical, Cardiovascular DWS
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Probe, Radiofrequency Lesion GXI
    Mixer, Cement, For Clinical Use JDZ
    Set, Administration, Intravascular FPA
    Single Use Instrument Tray OJV
    Angiography/Angioplasty Kit OEQ

    Proprietary Names

    ShortStop Grandstand Temporary Sharps Holder ShortStop Advantage Temporary Sharps Holder MiniStop Plus Closed Waste Basin ShortStop Temporary Sharps Holder BackStop Plus Closed Waste Basin Kensington Guide Wire Bone Biopsy System Madison™ Perforating Bone Biopsy System with Drill Westbrook™ Bone Biopsy System Madison Mini™ Bone Biopsy System Bedford™ Guided Hard Bone Biopsy System Huntington Guided, Perforating Bone Biospy System with Drill One Snare Endovascular Snare System ONE1501 InQwire Guidewire with Palladium Tip Merit Hydrophilic Guide Wire Merit InQwire® Amplatz Super Stiff Guide Wire SteadySheath & Shortie Liberator Beacon Tip Locking Stylet basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Prelude Sheath Introducer StabiliT ER2 Bone Cement and Saturate Mixing System StabiliT MX Fracture Kits StabiliT VP Vertebrosplasty Kit StabiliT VP Fracture Kits StabiliT MX Fracture Kits with PowerCURVE StabiliT Bone Cement and Saturate Mixing System Pinvise Torque Device SeaDragon Torque Device InQwire Guidewires Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Osseoflex CD-H Hydraulic Cement Delivery System Osseoflex SB Straight Balloon (10ga) Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Evolution RL & Evolution Shortie RL InQwire Amplatz Super Stiff Guide Wire Osseoflex SB Steerable Balloon (10Ga) Siege Vascular Plug InQwire Super Stiff Guide Wire Prelude Plastic Jacketed Guide Wire Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit X-Change Cement Dispensing Syringe Hydraulic Assembly Osseon Bone Filler Device (BFD) StabiliT Cement Delivery Syringe Hydraulic-Master Syringe Assembly Purge Assist Master Syringe Assembly DiamondTOUCH Syringe Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler Mighty Wire StabiliT Introducer and Delivery Instruments Maxxwire MultiPlex II Controller Activation Element, ERx bone cement Byrd Dilator Sheath Set Prelude Sheath Half Size (ACT) Rotating Adaptor Stopcock One Port Manifold Hemostasis Valve Adapter SafeSheath Sealing Adapter Merit Manifold DoublePlay Hemostasis Valve MYSHELL Hemostatic Valve FLO30 Honor hemostasis valve Passage Hemostasis Valve FLO40XR Merit Marquis Flow Switch Merit Marquis Stopcock Prelude Choice Hemostasis Valve Adapter PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing Access-9 H20 Torque Device AccessPLUS MBA Check Valve NeoVasc FLO50 10Fore Hemostasis Valve Guidewire Introducer MAP Torque Device & Introducer Fountain Catheter/Occluding Guide Wire VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill EN Snare Endovascular Snare System Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers InQwire Amplatz (IQA) Splashwire Hydrophilic Guide Wire SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit Fountain 4F Catheter & Occluding GW PinVise Torque Device ER2 Saturate Mixing System InQwire Guidewire-Prelude Introducer OneSnare Endovascular Snare System Merit PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Merit Administration Set CT Transfer Set Splashwire Hydrophilic guide wire Merit Convenience Kits Go2Wire Guide Wire K12 Procedure Kit K19 Combination Packs K05 Inflation Kit K23C Vein Accessory Kit K22C Vein Tray K12T - Procedure Kit K05T - Inflation Kit 10Fore Hemostasis Valve Kit K02-00873A, K02-01105A, K02-01481A

    Establishment Types

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