BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Merit Medical UK Limited

    Reg #: 3015309643 · FEI: 3015309643 · Expires 2026
    View on FDA
    Products
    129
    Proprietary Names
    407
    Establishment Types
    2
    Classifications
    129

    Registration Details

    Registration Name
    Merit Medical UK Limited
    Registration Number
    3015309643
    FEI Number
    3015309643
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 27, Suttons Business Park Sutton Park Avenue
    City
    Earley Reading
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K230636
    PMA Number
    P240023

    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 Parkway, --
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Catheter, Continuous Flush KRA
    Injector And Syringe, Angiographic DXT
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Catheter, Peritoneal, Long-Term Indwelling FJS
    Single Use Instrument Tray OJV
    Catheter, Intravascular, Diagnostic DQO
    Introducer, Catheter DYB
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Instrument, Biopsy KNW
    Transducer, Pressure, Catheter Tip DXO
    Unit, Cryosurgical, Accessories GEH
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Syringe, Piston FMF
    Syringe, Balloon Inflation MAV
    Wire, Guide, Catheter DQX
    Syringe, Balloon Inflation, Exempt PTM
    Set, Administration, Intravascular FPA
    Bedding, Disposable, Medical KME
    Marker, Radiographic, Implantable NEU
    Needle, Aspiration And Injection, Disposable GAA
    Tubing, Fluid Delivery FPK
    Dilator, Esophageal KNQ
    Tunneled Catheter Remover ODY
    Minor Surgical Procedures Tray PYB
    Catheter, Percutaneous DQY
    Transducer, Blood-Pressure, Extravascular DRS
    Clamp, Vascular DXC
    Tourniquet, Pneumatic KCY
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Intravenous Extension Tubing Set OJA
    Dispenser, Cement KIH
    Aspiration Thrombectomy Catheter QEZ
    Needle, Biopsy, Cardiovascular DWO
    Device, Vascular, For Promoting Embolization KRD
    Bottle, Collection, Vacuum KDQ
    Catheter, Hemodialysis, Implanted MSD
    Catheter, Steerable DRA
    Prosthesis, Esophageal ESW
    Accessories, Catheter KGZ
    Apparatus, Suction, Patient Care DWM
    Bronchoscope Accessory KTI
    Prosthesis, Tracheal, Expandable JCT
    Reverse Central Venous Recanalization System QJH
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Mechanical Thrombolysis Catheter QEY
    Biopsy Needle FCG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Mixer, Cement, For Clinical Use JDZ
    Trocar DRC
    Dialysis Administration Kit PEV
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
    Instruments, Surgical, Cardiovascular DWS
    Catheter And Tip, Suction JOL
    Computer, Blood-Pressure DSK
    Retention Device, Suture KGS
    Probe, Radiofrequency Lesion GXI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Orthopedic Manual Surgical Instrument LXH
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Bone Cement LOD
    Cardiovascular Catheter Sheath Introducer Kit OEX
    Table And Attachments, Operating-Room BWN
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Tourniquet, Nonpneumatic GAX
    Bandage, Elastic FQM
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Stylet, Surgical, General & Plastic Surgery GAH
    Syringe, Irrigating (Non Dental) KYZ
    System, Peritoneal, Automatic Delivery FKX
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Instrument, Surgical, Disposable KDC
    Kit, Surgical Instrument, Disposable KDD
    Stent, Ureteral FAD
    Angiography/Angioplasty Kit OEQ
    Device, Neurovascular Embolization HCG
    Device, Percutaneous Retrieval MMX
    Endoscopic Irrigation/Suction System OCX
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Peripheral Catheter Insertion Kit OWL
    Pulse-Generator, Pacemaker, External DTE
    Fluid Drainage Tray PXU
    Paracentesis Tray PYC
    Thoracentesis Tray PXI
    Catheter, Peritoneal Dialysis, Single Use FKO
    Catheter, Peritoneal GBW
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Tamp HXG
    Guide, Needle, Surgical GDF
    Cap, Device Disinfectant QBP
    Device, Biopsy, Endomyocardial DWZ
    Probe, Thermodilution KRB
    Cannula, Surgical, General & Plastic Surgery GEA
    Unit, Filter, Membrane JRL
    Support, Patient Position CCX
    Infusor, Pressure, For I.V. Bags KZD
    Stopcock, I.V. Set FMG
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
    Label Or Tag, Sterile LYV
    Bag, Bile Collecting EXF
    Catheter, Irrigation GBX
    Vacuum Syringe PUR
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Actuator, Syringe, Injector Type DQF
    Absorbable Lung Biopsy Plug OMT
    Electrode, Pacemaker, Temporary LDF
    Instrument, Manual, Surgical, General Use MDM
    Wire, Guide, Catheter, Exempt PTL
    Device, Intravascular Catheter Securement KMK
    Guide, Surgical, Instrument FZX
    Needle, Catheter GCB
    Dressing, Compression MHW
    Tape And Bandage, Adhesive KGX
    Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Universal Drainage Tray PPD
    Bit, Drill HTW
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Device, Measuring, For Panendoscope FDY
    Blade, Scalpel GES
    Cardiovascular Procedure Kit OEZ
    Endoscope Introducer Kit NWU
    Bulb, Inflation, For Endoscope FCY
    Dilator, Catheter GCC

    Proprietary Names

    Maestro Microcatheter Osseoflex SB Straight Balloon (10ga) Flex-Neck Extender/Repair Kit Merit Convenience Kits Worley Impress Angiographic Catheter PreludeEASE Hydrophilic Sheath Introducer, 7F Prelude IDeal Hydrophilic Sheath Introducer Prelude Wave Hydrophilic Sheath Introducer ReSolve ConvertX Biliary Stent System Prelude Prestige Splittable Sheath Introducer Temno Elite Biopsy Systems Physiological Reusable Pressure Transducer C2 Cryoballoon Ablation System Aspira Peritoneal Drainage System VACLOK Syringe K02 Syringe Kit (multiple K01) Dash 9F Hydrophilic Sheath Introducer Monarch Syringe Fluid Dispense System Flex-Neck Infant Catheter Merit InQwire® Amplatz Super Stiff Guide Wire basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Merit Administration Set CT Transfer Set DriPAD Super Absorbent Pad Corvocet Biopsy System SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) 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 Tubing, Fluid Delivery InQwire Guidewires Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon OuTake Catheter Extractor K13 Label Kit Ventrax Delivery System PinVise Torque Device Elation Wireguided Balloon Pressure Tubing PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Safeguard Pressure Assisted Device (12cm) Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. Adjustable Biopsy Port Seal BPS-A K08 Fluid Management Kit K04 - Tubing Kit Osseoflex CD-H Hydraulic Cement Delivery System ASAP Catheter Micro Plug Set Impress with Legato Hydrophilic Coating One-Vac Evacuated Drainage Bottle SCOUT Bx Delivery System Duramax Performa Diagnostic Intravascular Catheter HeartLight Deflectable Sheath SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System Resilience Fully Covered Esophageal Stent System Hydrophilic Prelude SNAP Splittable Sheath Introducer Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Aspira Pleural Drainage System Elation Pulmonary Balloon 4mm AEROmini Tracheobronchial Stent System Surfacer Inside-Out Access Catheter System Merit HeRO Graft Fountain 4F Catheter & Occluding GW Temno Original Temno ACT DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter ER2 Saturate Mixing System Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Low Profile Companion Sheath SwiftNINJA Steerable Microcatheter K14 Dialysis Kit Critiflo Dome Critiflo Achieve Pink Achieve Wrapsody Cell-Impermeable Endoprosthesis Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Repositional Chest Tube RTT14038MB Safedraw Blood Sampling System Osseoflex SB Straight Balloon (8ga) InQwire PreludeSYNC EZ Radial Compression Device Slip-Not Perchik Button Assembly ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit HeRO Graft Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome ASAP Aspiration Catheter ASAPLP Aspiration Catheter Secalon T Catheter Osseoflex SB Steerable Balloon (10Ga) InQwire Guidewire-Prelude Introducer K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board Merit Triboglide Syringe Quick Silver Corvocet Coaxial Introducer Exacta Percutaneous Sheath Introducer Finale Radial Compression System RADstat Radial Artery Compression Device SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) SAVI Applicator Kit EsophyX Z+ Device SafT Needle Direct Blood Transfer Mighty Wire Prelude Short Sheath Introducer Aero Tracheo Stent and Delivery System Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Elation Pulmonary Balloon Merit PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter Concierge Guiding Catheter Fountain Catheter/Occluding Guide Wire RXP (Rapid Exchange Flushing Syringe) ClariVein IC Infusion Catheter ReSolve Biliary Locking Drainage Catheter Fountain ValveTip Infusion Catheter Careflow Central Venous Catheter Stylette (rod obturator) PreludeEASE Hydrophilic Sheath Introducer, 4F-6F TRAM-P TRAM Cuff Implantor Sterilized Convenience Kits K01 Syringe Kit (1mL Polypropylene) 1 mL syringe(Polypropylene) Impress and Impress Legato Hydrophilic Angiographic Catheter Prelude Sheath Introducer Roadster Guide Sheath EvenMore Chronic Hemodialysis Catheter Aero DV Tracheobronchial Stent System ReSolve ConvertX Nephroureteral Stent System 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 EmboGold Microspheres Guidewire with Palladium Tip EN Snare Endovascular Snare System ROSE C2 Cryoballoon Endogrip Merit Hydrophilic Guide Wire InQwire Diagnostic (Support) Non-Vascular Guide Wire DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System K16 Microcatheter Kit Solo Pace Control ExxTended Catheter True Form Reshapable Guide Wire Hydrophilic Guidewire Pericardiocentesis Catheter Kit S-MAK XL Safety Paracentesis Tray (SPPT) Drainage Tubing Smart Tip Control Syringe Faller Trocar Alimaxx E TruCut 14Ga Miser Contrast Management System Osseoflex SB Steerable Balloon (8ga) Safeguard Radial Compression Device Thoracentesis Tray (TAPS) ProGuide Long Term Hemodialysis Catheter Meritrans Disposable Transducer HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath MultiPlex II Controller Activation Element, ERx bone cement SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Merit 1mL Syringe (COP) Peritoneal Dialysis Catheter Connector Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M) Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411) Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211) BioFlo Duramax Critiflo Disposable Diaphragm Dome STATSEAL WOUNDSEAL Safeguard Pressure Assisted Dressing (24cm) Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit Universal Coaxial Needles DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Guidewire Introducer MAP Torque Device & Introducer Merit Safety Needle Impress UAC Catheter Novatome Endomyocardial Biopsy Forceps Critikit Plus In-Line Room/ Ice Injectate 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 Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler MiniStop Filter Closed Waste Basin Temno Evolution Rad Rest Pressure Infusor Bags (PIB) FlowGuard S-MAK Embedding Tool Connecta PE Lines Micro Ace Advanced Micro Access System SureCross Support Catheter Prelude SNAP Splittable Sheath Introducer Merit Pursue Microcatheter Embosphere Microspheres Emboshpere PRO PAL (Pen and Labels) Family TruCut 18Ga QuadraSphere Q2 Microspheres QuadraSphere Microspheres Prelude Sheath Half Size (ACT) Siege Vascular Plug ARC Catheter One Snare Endovascular Snare System ONE1501 Merit Syringe Merit Drainage Depot ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter VacLok AT Syringe HeartSpan Steerable Sheath Introducer Merit Disposal Depot 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 SPINR High-Performance Guidewire Catheter Micro Ace Gold Advanced Micro Access System Spectraject Control Syringe Acutiy Universal Cutter BioSentry Tract Sealant System EndoMAXX Intellisystem Inflation Device Fluid Dispensing Syringe Vessel Dilator Solo Pace Fusion System (SOLOFUSE1) Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) Squirt Fluid Delivery System InQwire Amplatz Super Stiff Guide Wire Flex-Neck Catheter StabiliT Introducer and Delivery Instruments Maxxwire Ostial Pro Stent Positioning System ASAPLP Embolectomy Catheter HeartSpan Steerable Introducer Sheath Pinvise Torque Device SeaDragon Torque Device SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator Revolution Catheter Securement Dev. BowTie Guide Wire Insertion Device Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular SafeGuard Focus Compression Device SafeGuard Focus Cool Device SAVI Prep Device SAVI Spacer 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 5.5 F Worley Advanced LVI Lateral Vein Introducer OneSnare Endovascular Snare System SwiftNINJA Microcatheter Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes Integral Injectate Temperature Probe Catheter Connection Cable Disposable In Line Sensor Housing StayFix Fixation Device Brochoalveloar Lavage (BAL) Custom Convenience Kit DuraFlow 2 Hemodialysis Catheter Sidecar External Working Channel (FG-1011) Bath Probe Catheter Connection Cables and Cardia Computer Injectate Sensor Cable K10 Waste Management Kit K10T - Waste Management Kit Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Go2Wire Guide Wire VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill H20 Guidewire Prelude Plastic Jacketed Guide Wire SCOUT Console and Accessory Cart Aerosizer Futura Safety Scalpel K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit SCOUT MD Single-Use Handpieces K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit Insufflation Set ReSolve Dilators Non-vascular tissue dilators

    Establishment Types

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