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
- [email protected]
- Phone
- 801 2084389
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2006-02-14 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2023-03-15 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2018-07-17 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2003-12-18 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2019-07-12 |
| Universal Drainage Tray | PPD | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2018-04-18 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2025-01-22 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2007-12-19 |
| Reverse Central Venous Recanalization System | QJH | Class 2 | Cardiovascular | No | 2023-06-14 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2017-07-27 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-08-16 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2015-11-02 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2007-12-07 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2017-07-24 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2021-06-23 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-09-11 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2023-06-08 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-10-14 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 1992-07-14 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2013-10-24 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2015-08-20 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2016-12-06 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2001-07-14 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2013-11-11 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2016-03-28 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-01-17 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-09-09 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2018-08-01 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2012-04-12 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2018-08-01 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2015-05-18 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2013-06-27 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2013-09-19 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2003-12-18 |
| Absorbable Lung Biopsy Plug | OMT | Class 2 | General, Plastic Surgery | No | 2023-06-08 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-09-09 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2018-03-27 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2019-07-12 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2023-10-18 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2023-04-04 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2016-03-30 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2026-02-12 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-06-11 |
| Cardiovascular Catheter Sheath Introducer Kit | OEX | Class 2 | Cardiovascular | No | 2018-08-01 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-08-26 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2017-06-16 |
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