BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Merit Medical Asia Company Limited

    Reg #: 3015225571 · FEI: 3015225571 · Expires 2026
    View on FDA
    Products
    116
    Proprietary Names
    373
    Establishment Types
    1
    Classifications
    116

    Registration Details

    Registration Name
    Merit Medical Asia Company Limited
    Registration Number
    3015225571
    FEI Number
    3015225571
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rm 614 6/F Tsim Sha Tsui Center, 66 Mody Road
    City
    Tsim Sha Tsui
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K970159
    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, Peritoneal, Long-Term Indwelling FJS
    Kit, Surgical Instrument, Disposable KDD
    Paracentesis Tray PYC
    Catheter, Intravascular, Diagnostic DQO
    Device, Percutaneous Retrieval MMX
    Wire, Guide, Catheter DQX
    Set, Administration, Intravascular FPA
    Universal Drainage Tray PPD
    Tunneled Catheter Remover ODY
    Needle, Biopsy, Cardiovascular DWO
    Cardiovascular Procedure Kit OEZ
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Introducer, Catheter DYB
    Stent, Ureteral FAD
    Catheter, Hemodialysis, Implanted MSD
    Unit, Filter, Membrane JRL
    Device, Measuring, For Panendoscope FDY
    Absorbable Lung Biopsy Plug OMT
    Orthopedic Manual Surgical Instrument LXH
    Tourniquet, Nonpneumatic GAX
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Bronchoscope Accessory KTI
    Catheter, Continuous Flush KRA
    Mechanical Thrombolysis Catheter QEY
    Endoscopic Irrigation/Suction System OCX
    Unit, Cryosurgical, Accessories GEH
    Instrument, Biopsy KNW
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Dilator, Catheter GCC
    Clamp, Vascular DXC
    Instrument, Surgical, Disposable KDC
    Syringe, Piston FMF
    Thoracentesis Tray PXI
    Prosthesis, Tracheal, Expandable JCT
    Bandage, Elastic FQM
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE
    Support, Patient Position CCX
    Prosthesis, Esophageal ESW
    Injector And Syringe, Angiographic DXT
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Bit, Drill HTW
    Marker, Radiographic, Implantable NEU
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Bulb, Inflation, For Endoscope FCY
    Catheter, Percutaneous DQY
    Tamp HXG
    Dispenser, Cement KIH
    Bag, Bile Collecting EXF
    Mixer, Cement, For Clinical Use JDZ
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
    Aspiration Thrombectomy Catheter QEZ
    Transducer, Blood-Pressure, Extravascular DRS
    Syringe, Irrigating (Non Dental) KYZ
    Needle, Aspiration And Injection, Disposable GAA
    Table And Attachments, Operating-Room BWN
    Cannula, Surgical, General & Plastic Surgery GEA
    Tourniquet, Pneumatic KCY
    Catheter, Peritoneal GBW
    Device, Vascular, For Promoting Embolization KRD
    Biopsy Needle FCG
    Catheter, Irrigation GBX
    Peripheral Catheter Insertion Kit OWL
    Bedding, Disposable, Medical KME
    Intravenous Extension Tubing Set OJA
    Guide, Needle, Surgical GDF
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Electrode, Pacemaker, Temporary LDF
    Bottle, Collection, Vacuum KDQ
    System, Peritoneal, Automatic Delivery FKX
    Accessories, Catheter KGZ
    Reverse Central Venous Recanalization System QJH
    Label Or Tag, Sterile LYV
    Apparatus, Suction, Patient Care DWM
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Dressing, Compression MHW
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Dialysis Administration Kit PEV
    Device, Biopsy, Endomyocardial DWZ
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Single Use Instrument Tray OJV
    Retention Device, Suture KGS
    Catheter, Peritoneal Dialysis, Single Use FKO
    Dilator, Esophageal KNQ
    Stylet, Surgical, General & Plastic Surgery GAH
    Needle, Catheter GCB
    Blade, Scalpel GES
    Syringe, Balloon Inflation MAV
    Infusor, Pressure, For I.V. Bags KZD
    Fluid Drainage Tray PXU
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tubing, Fluid Delivery FPK
    Angiography/Angioplasty Kit OEQ
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Wire, Guide, Catheter, Exempt PTL
    Instruments, Surgical, Cardiovascular DWS
    Catheter, Steerable DRA
    Minor Surgical Procedures Tray PYB
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
    Endoscope Introducer Kit NWU
    Cardiovascular Catheter Sheath Introducer Kit OEX
    Tape And Bandage, Adhesive KGX
    Guide, Surgical, Instrument FZX
    Cap, Device Disinfectant QBP
    Pulse-Generator, Pacemaker, External DTE
    Bone Cement LOD
    Catheter And Tip, Suction JOL
    Syringe, Balloon Inflation, Exempt PTM
    Trocar DRC
    Vacuum Syringe PUR
    Device, Intravascular Catheter Securement KMK
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

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

    Establishment Types

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