FDA Registration Active 🇲🇽 Mexico

Merit Maquiladora Mexico, S. DE R.L. DE C.V.

Reg #: 3011642792 · FEI: 3011642792 · Expires 2026
Products
54
Proprietary Names
174
Establishment Types
3
Classifications
54

Registration Details

Registration Name
Merit Maquiladora Mexico, S. DE R.L. DE C.V.
Registration Number
3011642792
FEI Number
3011642792
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Avenida Sor Juana Ines de la Cruz, 19970 Interior B, Edificio 2, Parque Industrial Frontera
City
Tijuana Baja California
Country
MX

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 W Merit Pkwy
City
South Jordan
State
UT
ZIP
84095
Country
US
Phone
801 2084389

Products

Device Name Product Code
Dialysis Administration Kit PEV
Device, Intravascular Catheter Securement KMK
Dilator, Vessel, For Percutaneous Catheterization DRE
Intravenous Extension Tubing Set OJA
Infusor, Pressure, For I.V. Bags KZD
Stents, Drains And Dilators For The Biliary Ducts FGE
Universal Drainage Tray PPD
Clamp, Vascular DXC
Device, Biopsy, Endomyocardial DWZ
Tubing, Fluid Delivery FPK
Reverse Central Venous Recanalization System QJH
Syringe, Balloon Inflation, Exempt PTM
Catheter, Intravascular, Diagnostic DQO
Introducer, Catheter DYB
Catheter, Irrigation GBX
Trocar DRC
Bag, Bile Collecting EXF
Bottle, Collection, Vacuum KDQ
Tape And Bandage, Adhesive KGX
Catheter, Hemodialysis, Implanted MSD
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Needle, Catheter GCB
Support, Patient Position CCX
Biopsy Needle FCG
System, X-Ray, Tomography, Computed JAK
Needle, Aspiration And Injection, Disposable GAA
Injector, Vertebroplasty (Does Not Contain Cement) OAR
Instrument, Biopsy KNW
Instruments, Surgical, Cardiovascular DWS
Bandage, Elastic FQM
Cardiovascular Procedure Kit OEZ
Peripheral Catheter Insertion Kit OWL
Set, Administration, Intravascular FPA
Minor Surgical Procedures Tray PYB
Single Use Instrument Tray OJV
Retention Device, Suture KGS
Ureteroscope And Accessories, Flexible/Rigid FGB
Accessories, Catheter KGZ
Absorbable Lung Biopsy Plug OMT
Tourniquet, Nonpneumatic GAX
Dressing, Compression MHW
Guide, Needle, Surgical GDF
Stent, Ureteral FAD
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
Dilator, Catheter GCC
Apparatus, Suction, Patient Care DWM
Tourniquet, Pneumatic KCY
Endoscope Introducer Kit NWU
Angiography/Angioplasty Kit OEQ
Peripheral Mechanical Thrombectomy With Aspiration QEW
Blade, Scalpel GES
Cardiovascular Catheter Sheath Introducer Kit OEX
Bedding, Disposable, Medical KME
Injector And Syringe, Angiographic DXT

Proprietary Names

K14 Dialysis Kit Revolution Catheter Securement Dev. S-MAK K08 Fluid Management Kit K04 - Tubing Kit Pressure Infusor Bags (PIB) ReSolve ConvertX Biliary Stent System K10 Waste Management Kit K10T - Waste Management Kit PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Novatome Endomyocardial Biopsy Forceps Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Surfacer Inside-Out Access Catheter System ReSolve Biliary Locking Drainage Catheter PreludeSYNC EZ Radial Compression Device basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Impress and Impress Legato Hydrophilic Angiographic Catheter Hydrophilic Prelude SNAP Splittable Sheath Introducer ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Merit Drainage Depot One-Vac Evacuated Drainage Bottle Safeguard Pressure Assisted Dressing (24cm) StayFix Fixation Device BioFlo Duramax 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 Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Rad Rest Micro Ace Advanced Micro Access System Merit Disposal Depot Corvocet Coaxial Introducer 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 5.5 F Worley Advanced LVI Lateral Vein Introducer 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 Corvocet Biopsy System Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Low Profile Companion Sheath SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit K16 Microcatheter Kit Miser Contrast Management System K13 Label Kit Merit Convenience Kits Impress with Legato Hydrophilic Coating Worley Impress Angiographic Catheter Vessel Dilator Slip-Not Perchik Button Assembly PORT SEAL / BPS-Y Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Prelude SNAP Splittable Sheath Introducer Temno Evolution BioSentry Tract Sealant System Achieve Pink Achieve TruCut 18Ga Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Safeguard Radial Compression Device EvenMore Chronic Hemodialysis Catheter Finale Radial Compression System RADstat Radial Artery Compression Device SafeGuard Focus Compression Device SafeGuard Focus Cool Device Universal Coaxial Needles ReSolve ConvertX Nephroureteral Stent System Aspira Pleural Drainage System ReSolve Dilators Non-vascular tissue dilators TruCut 14Ga Safeguard Pressure Assisted Device (12cm) Aspira Peritoneal Drainage System DuraFlow 2 Hemodialysis Catheter K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit Performa Diagnostic Intravascular Catheter Prelude Prestige Splittable Sheath Introducer Impress UAC Catheter 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 PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) RoVo Mechanical Thrombectomy Catheter Temno Original Temno ACT Futura Safety Scalpel Duramax SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Roadster Guide Sheath K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) DriPAD Super Absorbent Pad S-MAK XL Merit Administration Set CT Transfer Set Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device