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

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3011642792

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011642792
FEI Number
3011642792
Entity Name
Merit Maquiladora Mexico, S. DE R.L. DE C.V.
City/State/Country
Tijuana Baja California, MX
Establishment Address
Avenida Sor Juana Ines de la Cruz, 19970 Interior B, Edificio 2, Parque Industrial Frontera, Tijuana Baja California 22630, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Merit Medical Systems, Inc. (Owner Number: 1721504)
Owner / Operator Contact Address
1600 West Merit Parkway, --, South Jordan, UT 84095, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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. Corvocet Biopsy System 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 Aspira Pleural Drainage System Safeguard Pressure Assisted Device (12cm) Aspira Peritoneal Drainage System DuraFlow 2 Hemodialysis Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2018-08-01
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2006-02-14
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-03-15
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2018-07-17
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2003-12-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-07-12
PPD Universal Drainage Tray Gastroenterology, Urology Class 2 876.5130 2018-08-01
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2018-04-18
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2025-01-22
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2007-12-19
QJH Reverse Central Venous Recanalization System Cardiovascular Class 2 870.1342 2023-06-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-12-02
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2017-01-25
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2017-07-27
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-08-16
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-11-02
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2003-06-05
DRC Trocar Cardiovascular Class 2 870.1390 2007-12-07
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2017-07-24
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2021-06-23
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-10-25
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2013-09-11
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-10-14
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 1992-07-14
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2013-10-24
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-10-09
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2015-08-20
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-12-06
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2001-07-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-10-09
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2013-11-11
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2016-03-28
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-01-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-01-23
FQM Bandage, Elastic General Hospital Class 1 880.5075 2020-09-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-11-21
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-13
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2018-08-01
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2018-08-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-04-12
PYB Minor Surgical Procedures Tray General, Plastic Surgery Class 1 878.4800 2018-08-01
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2015-05-18
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-10-21
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-06-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2013-09-19
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2003-12-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-04-14
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-03-15
OMT Absorbable Lung Biopsy Plug General, Plastic Surgery Class 2 878.4755 2023-06-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-15
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-10-25
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2003-06-05
MHW Dressing, Compression General Hospital Class 1 880.5075 2020-09-09
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2018-03-27
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-07-12
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2023-10-18
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2014-07-02
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-04-02
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2023-04-04
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2016-03-30
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2020-09-02
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08

Official Correspondent

No official correspondent registered.

US Agent Details

John Knorpp Business: MERIT MEDICAL SYSTEMS, INC. Email: jknorpp@merit.com Phone: (801) 2084389

Related Public Records

Same Entity

Merit Medical Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021179744 VIEW POINT MEDICAL, INC. Carlsbad, CA, US
3012276280 KA Medical Arden Hills, MN, US
2032338 Merit Medical Systems, Inc. ALISO VIEJO, CA, US
1125782 MERIT MEDICAL SYSTEMS, INC Chester, VA, US
9615728 BIOSPHERE MEDICAL, S.A. Roissy Val-d'Oise, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K902734 Olympus Corp. PR CANNULAS 1990-08-22
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2017 Merit Medical Systems, Inc. 2
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0026-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0027-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.

Similar Registrations

Registration Number Establishment Name Location
3006950086 Merit Medical Nederland BV Maastricht Airport Limburg, NL
1047429 AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 TOANO, VA, US
3007329020 Cardinal Health 200, LLC El Paso, TX, US
1423537 Cardinal Health 200, LLC Waukegan, IL, US
1721504 MERIT MEDICAL SYSTEMS, INC. South Jordan, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011642792. Last updated year: 2026. Please use registration number 3011642792 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.