Data / Medical devices / Mexico / Merit Maquiladora Mexico, S. DE R.L. DE C.V.
Merit Maquiladora Mexico, S. DE R.L. DE C.V.: FDA-registered device maker in Tijuana Baja California, Mexico, 1 510(k) clearance
Merit Maquiladora Mexico, S. DE R.L. DE C.V. is registered with the FDA (registration 3011642792) in Tijuana Baja California, Mexico. It lists 55 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011642792
- Address
- Avenida Sor Juana Ines de la Cruz 19970 Interior B, Edificio 2, Parque Industrial Frontera, Tijuana Baja California, Mexico, 22630
- Owner or operator
- Merit Medical Systems, Inc. (1721504)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- July 14, 1992
- Registered through
- 2027
- Brand names listed
- 10Fore Hemostasis Valve, 10Fore Hemostasis Valve Kit, 5.5 F Worley Advanced LVI Lateral Vein Introducer, Access-9, AccessPLUS, Achieve, Advance Angiographic Needle, Aspira Peritoneal Drainage System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Absorbable Lung Biopsy Plug | OMT | 2 | Contract manufacturer | accessdata.fda.gov |
| Accessories, Catheter | KGZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Angiography/Angioplasty Kit | OEQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Patient Care | DWM | 2 | Contract manufacturer | accessdata.fda.gov |
| Bag, Bile Collecting | EXF | 2 | Contract manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer | accessdata.fda.gov |
| Biopsy Needle | FCG | 2 | Contract manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Contract manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Cardiovascular Catheter Sheath Introducer Kit | OEX | 2 | Contract manufacturer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Hemodialysis, Implanted | MSD | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Contract manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Biopsy, Endomyocardial | DWZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Contract manufacturer | accessdata.fda.gov |
| Dialysis Administration Kit | PEV | 2 | Contract manufacturer | accessdata.fda.gov |
| Dilator, Catheter | GCC | 1 | Contract manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Contract manufacturer | accessdata.fda.gov |
| Endoscope Introducer Kit | NWU | 2 | Contract manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Contract manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Contract manufacturer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Contract manufacturer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Contract manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Contract manufacturer | accessdata.fda.gov |
| Intravenous Extension Tubing Set | OJA | 2 | Contract manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Contract manufacturer | accessdata.fda.gov |
| Minor Surgical Procedures Tray | PYB | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Contract manufacturer | accessdata.fda.gov |
| Peripheral Catheter Insertion Kit | OWL | 2 | Contract manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Contract manufacturer | accessdata.fda.gov |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | 2 | Contract manufacturer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Contract manufacturer | accessdata.fda.gov |
| Reverse Central Venous Recanalization System | QJH | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer | accessdata.fda.gov |
| Single Use Instrument Tray | OJV | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stent, Ureteral | FAD | 2 | Contract manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Contract manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Contract manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Contract manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | Contract manufacturer | accessdata.fda.gov |
| Trocar | DRC | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Contract manufacturer | accessdata.fda.gov |
| Universal Drainage Tray | PPD | 2 | Contract manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| July 13, 2026 | K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | DQX | Substantially Equivalent | Merit Medical Ireland , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.