BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Merit Medical Nederland BV

    Reg #: 3006950086 · FEI: 3006950086 · Expires 2026
    View on FDA
    Products
    129
    Proprietary Names
    406
    Establishment Types
    1
    Classifications
    129

    Registration Details

    Registration Name
    Merit Medical Nederland BV
    Registration Number
    3006950086
    FEI Number
    3006950086
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Amerikalaan 42
    City
    Maastricht Airport Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K083625
    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
    Prosthesis, Tracheal, Expandable JCT
    Catheter, Percutaneous DQY
    Catheter, Continuous Flush KRA
    Dialysis Administration Kit PEV
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Probe, Radiofrequency Lesion GXI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Absorbable Lung Biopsy Plug OMT
    Cannula, Surgical, General & Plastic Surgery GEA
    Introducer, Catheter DYB
    Prosthesis, Esophageal ESW
    Wire, Guide, Catheter DQX
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Catheter, Hemodialysis, Implanted MSD
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Marker, Radiographic, Implantable NEU
    Transducer, Blood-Pressure, Extravascular DRS
    Dilator, Esophageal KNQ
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Mechanical Thrombolysis Catheter QEY
    Actuator, Syringe, Injector Type DQF
    Dilator, Catheter GCC
    Syringe, Piston FMF
    Catheter, Intravascular, Diagnostic DQO
    Computer, Blood-Pressure DSK
    Mixer, Cement, For Clinical Use JDZ
    Device, Vascular, For Promoting Embolization KRD
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Catheter, Peritoneal, Long-Term Indwelling FJS
    Universal Drainage Tray PPD
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Bedding, Disposable, Medical KME
    Stylet, Surgical, General & Plastic Surgery GAH
    Bandage, Elastic FQM
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Support, Patient Position CCX
    Instrument, Biopsy KNW
    Probe, Thermodilution KRB
    Paracentesis Tray PYC
    Tunneled Catheter Remover ODY
    Syringe, Balloon Inflation MAV
    Injector And Syringe, Angiographic DXT
    Catheter And Tip, Suction JOL
    Unit, Filter, Membrane JRL
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Endoscope Introducer Kit NWU
    Device, Neurovascular Embolization HCG
    Aspiration Thrombectomy Catheter QEZ
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
    Infusor, Pressure, For I.V. Bags KZD
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Instrument, Manual, Surgical, General Use MDM
    Bronchoscope Accessory KTI
    Clamp, Vascular DXC
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Pulse-Generator, Pacemaker, External DTE
    Peripheral Catheter Insertion Kit OWL
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Apparatus, Suction, Patient Care DWM
    Bag, Bile Collecting EXF
    Catheter, Steerable DRA
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Cardiovascular Catheter Sheath Introducer Kit OEX
    Wire, Guide, Catheter, Exempt PTL
    Transducer, Pressure, Catheter Tip DXO
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Biopsy Needle FCG
    Single Use Instrument Tray OJV
    Kit, Surgical Instrument, Disposable KDD
    Bone Cement LOD
    Bulb, Inflation, For Endoscope FCY
    Dressing, Compression MHW
    Orthopedic Manual Surgical Instrument LXH
    Fluid Drainage Tray PXU
    Device, Percutaneous Retrieval MMX
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Guide, Needle, Surgical GDF
    Endoscopic Irrigation/Suction System OCX
    System, Peritoneal, Automatic Delivery FKX
    Bit, Drill HTW
    Device, Biopsy, Endomyocardial DWZ
    Cardiovascular Procedure Kit OEZ
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE
    Table And Attachments, Operating-Room BWN
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Device, Intravascular Catheter Securement KMK
    Needle, Catheter GCB
    Trocar DRC
    Dispenser, Cement KIH
    Vacuum Syringe PUR
    Catheter, Peritoneal GBW
    Stent, Ureteral FAD
    Minor Surgical Procedures Tray PYB
    Bottle, Collection, Vacuum KDQ
    Needle, Biopsy, Cardiovascular DWO
    Tourniquet, Nonpneumatic GAX
    Catheter, Irrigation GBX
    Reverse Central Venous Recanalization System QJH
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Set, Administration, Intravascular FPA
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Angiography/Angioplasty Kit OEQ
    Accessories, Catheter KGZ
    Label Or Tag, Sterile LYV
    Needle, Aspiration And Injection, Disposable GAA
    Blade, Scalpel GES
    Instrument, Surgical, Disposable KDC
    Tubing, Fluid Delivery FPK
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Syringe, Irrigating (Non Dental) KYZ
    Unit, Cryosurgical, Accessories GEH
    Catheter, Peritoneal Dialysis, Single Use FKO
    Tourniquet, Pneumatic KCY
    Device, Measuring, For Panendoscope FDY
    Retention Device, Suture KGS
    Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
    Cap, Device Disinfectant QBP
    Instruments, Surgical, Cardiovascular DWS
    Tape And Bandage, Adhesive KGX
    Stopcock, I.V. Set FMG
    Syringe, Balloon Inflation, Exempt PTM
    Guide, Surgical, Instrument FZX
    Intravenous Extension Tubing Set OJA
    Electrode, Pacemaker, Temporary LDF
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Tamp HXG
    Thoracentesis Tray PXI

    Proprietary Names

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

    Establishment Types

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