BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Teleflex Medical de Tecate, S. de R.L de C.V.

    Reg #: 3003898360 · FEI: 3003898360 · Expires 2026
    View on FDA
    Products
    72
    Proprietary Names
    305
    Establishment Types
    4
    Classifications
    72

    Registration Details

    Registration Name
    Teleflex Medical de Tecate, S. de R.L de C.V.
    Registration Number
    3003898360
    FEI Number
    3003898360
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    (A Teleflex Medical Company), Prolongacion Mision Eusebio Kino No. 1316,Rancho El Descanso
    City
    TECATE Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K220971
    PMA Number
    P180025

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    US Agent

    Business Name
    Teleflex, Inc.
    Contact Name
    Divya Raman
    Address
    3015 Carrington Mill Boulevard
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    612 4231738

    Products

    Device Name Product Code
    Temporary, Internal Use Hemostatic POD
    Clip, Implantable FZP
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Intravascular, Diagnostic DQO
    Device, Hemostasis, Vascular MGB
    Catheter, Percutaneous DQY
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Catheter, Irrigation GBX
    Instrument, Surgical, Non-Powered HAO
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Pump, Infusion, Elastomeric MEB
    Tube, Tracheal (W/Wo Connector) BTR
    Clip, Vascular DSS
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Laparoscope, General & Plastic Surgery GCJ
    Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
    Applier, Hemostatic Clip HBT
    Introducer, Catheter DYB
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Catheter, Ultrasound, Intravascular OBJ
    Catheter, Peritoneal GBW
    Syringe, Balloon Inflation MAV
    Injector And Syringe, Angiographic DXT
    Wire, Guide, Catheter DQX
    Laryngoscope, Rigid CCW
    Orthosis, Limb Brace IQI
    Airway, Oropharyngeal, Anesthesiology CAE
    Bag, Reservoir BTC
    Apparatus, Electrosurgical HAM
    Connector, Airway (Extension) BZA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Applicator (Laryngo-Tracheal), Topical Anesthesia CCT
    Stylet, Tracheal Tube BSR
    Implantable Transprostatic Tissue Retractor System PEW
    Filter, Bacterial, Breathing-Circuit CAH
    Clip, Scalp HBO
    Catheter, Conduction, Anesthetic BSO
    Applier, Surgical, Clip GDO
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Tube, Tracheostomy (W/Wo Connector) BTO
    Catheter, Urological KOD
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Aspiration Thrombectomy Catheter QEZ
    Apparatus, Gas-Scavenging CBN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Endoscopic Bite Block MNK
    Tracheobronchial Suction Catheter Kit OFR
    Staple, Removable (Skin) GDT
    Hook, Surgical, General & Plastic Surgery GDG
    Insufflator, Laparoscopic HIF
    Stapler, Skin QQS
    Tube, Bronchial (W/Wo Connector) BTS
    Catheter Introducer Kit OFC
    Tube, Laryngectomy KAC
    Endoscopic Cholangiogram Kit NWT
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile NNY
    Staple, Implantable GDW
    System, Surgical, Computer Controlled Instrument NAY
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Strap, Head, Gas Mask BTK
    Continuous Measurement Thermometer FLL
    Dislodger, Stone, Biliary LQR
    Spirometer, Therapeutic (Incentive) BWF
    Catheter, Cholangiography GBZ

    Proprietary Names

    QuikClot Control+ McKenzie V Clips RS MULTIPLE ATOMIZER AND TIP ENT NON-VENTILATORY NEBULIZER MAD Nasal Mist MAD Nasal VaxINator Mucosal Atomization Device (MAD) NON=VENTILATORY MEDICINAL NEBULIZE AVA NEB NEBULIZER TIP ENT MULTIPLE ATOMIZERS ATOMIZER Ringer Perfusion Balloon Catheter Langston dual lumen catheter MANTA Vascular Closure Device MANTA Depth Locator HEMOLOK Ligating Clips & Cartridges TrapLiner catheter. Model Numbers: 5566-TrapLiner catheter 6F, 5567-TrapLiner catheter 7F, 5568-TrapLiner catheter 8F QuikClot Radial Pleur-evac Suction catheter with saline KMEDIC WECK Pilling HUMID-VENT HEAT AND MO MULTIPLE HEAT HUMID-FLO MOISTURE ARTIFICIAL NOSE CONDENSER HEAT AND MOISTURE VARIOUS TYPES OF HEAT AND MOISTURE EXCHANGERS Autofuser Teleflex ISIS HVT Horizon Sher-I-Bronch Endobronchial Tube GuideLiner Coast Catheter M5270 GuideLiner Coast,M5271 GuideLiner Coast, M5272 GuideLiner Coast,M5273 GuideLiner Coast Directable Cholangiography catheter ADAPT LAPAROSCOPIC TAUT DA VINCI Weck Vista Standard Staple-Line Reinforcement HEMOLOK SMX Ligating Clip Polymer HEMOLOCK Hemolok RuschFlex, armoured Tracheal tube RuschFlex, armoured tracheal tube, cuffed Sheridan Spiral-Flex Reinforced Endotracheal Tube PILLING HEMOLOK Clip Appliers. Horizon, Hem-O-Clip Traditional, Hem-O-Clip Plus, Hem-O-Lok, VSI Micro-Introducer Kit CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS PERITONEAL CATHETER GERY WECK VISTA INTRADUCER PERITONEAL#GENERAL AND PLASTIC SUR MULTIPLE PERITONEAL CATHETERS Taut Bandit guidewire. Modell numbers:7444 Bandit Guidewire 200cm5Pk and 7445 Bandit Guidewire 300cm5PK EquipLite Standard Laryngoscope Blades and Handles Rusch GreenLite Shucman 2 DispoLED DispoGrip GreenSpec EquipLED TruLED TruLite Secure GreenLED Fiber Optic Laryngoscope Blades and Handles Dolphin SnapLight Rusch Polaris Accumed Wrist Splint. Model Numbers 3565-Accumed PWPS and 3560-Accumed II, Flat HEMOCLIP AUTOMATIC CLIPS MEDIUM Hem-o-lok Plus PurplePlus Weck LMA ProSeal LMA Fastrach (SU) LMA Unique (Silicone Cuff) LMA Supreme LMA Flexible (SU) Oropharyngeal Guedel Tube Black LMA Cuff-Deflator LMA Unique (Silicone Cuff) Cuff Pilot LMA ProSeal Introducer LMA Unique Evo Cuff Pilot LMA Protector Cuff Pilot LMA Fastrach LMA Flexible LMA ProSeal Cuff Deflator LMA Protector LMA Unique Evo LMA Classic Excel LMA Unique LMA Gastro Cuff Pilot LMA Unique PreCurved LMA Classic LMA Flexible PreCurved LMA Unique PreCurved Cuff Pilot LMA NovaPlus LMA Supreme Plus Pack LMA Flexible PreCurved Cuff Pilot MADgic Airway LMA Fastrach Stabiliser Rod LMA Unique (S) Cuff Pilot LMA Flexible (S) LMA Unique (S) LMA Flexible (S) Cuff Pilot Cath-Guide Guedel Airway Airway Lifesaver Kit Ovassapian Airway Dual Channel Airway Rusch Breathing Bag Hudson Neoprene Pecan Breathing Bag Rusch Pecan Breathing Bag Hudson Anesthesia Circuit Hudson RCI Test Lung Hudson Anesthesia Breathing Bags Hudson Anesthesia Circuit Assessories Rusch Anesthesia Breathing Bags ADAPT UNIVERSAL LAPAROSCOPIC PORT, WECKVISTA bipolar electosurgical forcep Y Connector Elbow Connector M Connector Connector Sher-I-Swiv Double Swivel Connector CPRAM Respiratory Assist Device Hudson RCI Adaptors and Connectors Rusch Connector Oxygenator Rusch Connector Trach Tee Fitting Hudson RCI Tubing Hudson RCI Sensor Tee Rusch Connector with Barbed Elbow Gibeck RCI Softech Bi-Flo Cannula Hudson RCI Softech Bi-Flo Cannula Ligation Clips MADgic Sheridan Soft-Tip Intubating Stylet Sher-I-Swiv/FO Double Swivel Connector Sheridan Sher-I-Slip Intubating Stylet Rusch Endotracheal Tube Stylet UroLift System UL400 Tracheal Tube QuikClot Interventional Arrow VPS G4 System HEM O LOCK LIGATION CLIPS RUSCH AGT PVC PREFORM NASAL VPS Rhythm DLX Device with TipTracker Technology NaviCurve Stylet TipTracker Stylet HUMID-VENT FILTER SMALL HUMID-VENT FILTER COMPACT Raney Scalp Clips Epidural Catheter Weck, Horizon, Hemoclip Traditional, Hemoclip Plus HORIZON HEMOCLIP R350 guidewire Model Number: 7390 R350 V2 Guidewire, 5pk Weck®, Hem-o-lok®, Auto Endo5® Teleflex VPS Rhythm Device with TipTracker Technology Hudson Sampling Lines and Filters Gas Sampling Lines Multiple Ventilator T Corr A Tube Smooth Flo Corr A Tube II Corr A Flex Rusch Sampling Lines, Rusch Anesthesia Circuit Accessories Catheter Mount Rusch Corrugated Tubing Venti-Comp Gibeck RCI SOFTFLEX CONMED ENDO5 SuperCross FT (Model numbers:5340 SuperCross 014FT, 130cm and 5341 SuperCross 014 FT, 150cm) HEMOCLIP Ligating Clip Med/Lrg Arrow VPS System, VPS Bedside procedure Kit and VPS Stylet component Warrior guidewire Model Numbers: 7389 Warrior Guidewire 300CM and 7388 Warrior Guidewire 200CM SHERIDAN LITA Cuffed Endotracheal Tube Sheridan Lar-A-Ject Reinforced Laryngectomy Tube SIMS Anesthesia Breathing Circuit Hudson Sampling lines and Filters Rusch Anesthesia Circuit Accessories Rusch Pediatric Rebreathing Circle Systems ISO-GARD Drain Circuit Technology Hudson RCI Conventional Breathing Circuits Rusch Face Mask Plug Rusch CPRAM Anesthesia Circuits Hudson CPRAM Anesthesia Circuits Rusch sampling lines and filters Anesthesia Circuit Sheridan Flex-C-Pap Rusch Adult Anesthesia circuit Rusch Disposable Adult Rebreathing Circle Systems Rusch RCI Conventional Breathing Circuits Hudson Anesthesia Circuit Accessories Rusch EPDM FLEX CONNECTOR Rusch Anesthesia Circuit Rusch Adult Rebreathing Circle Systems Hudson Disposable Adult Rebreathing Circle Systems Hudson Pediatric Rebreathing Circle Systems Hudson RCI Rusch RCI Hudson Non-Rebreathing Single Limb Systems Hudson Adult Rebreathing Circle Systems Rusch Non-Rebreathing Single Limb Systems Pronto V4 ISO-Gard Mask Horizon Ligating Clips, Titanium Suction Tube LMA Fastrach ETT QuikClot Combat Gauze, QuikClot Combat Gauze TraumaPad QuikClot Bleeding Control Dressing QuickClot EMS Bite Gard Hudson Bite-Guard Bite-Gard Oral Bite Block SHER-I-BRONCH ACCESSORY PACK VISISTAT STAPLER Multiple Tracheal Tubes W/O Connect Arrow VPS stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS PLASTIC SURGERY SURGICAL HOOKS SURGICAL HOOK FOR ENT MULTIIPLE SHERIDAN DIFFERENTIAL VENT. TUBES MULTIPLE TRACHEAL-BRONCHIAL LASER RESISTANT TRACH TUBE TAUT INSUFFLATION NEEDLE Stapler, Skin Rusch Easytube RUSCH Double lumen Bronchial tube, White RUSCH Double lumen Bronchial tube, Carlens VSI Micro-Introducer™ Kit UroLift 2 System Weck, Hem-o-lok, Hemolok UroLift Advanced Tissue Control (ATC) System LARYNGECTOMY MULTIPLE LARYNGECTOMY TUBES Twin-Pass Dual Access Catheter Aquatherm Sprotte Needle SUPERCROSS External Catheter Condom Catheter Rusch Male Exeternal Catheter PILLING WECK M-20 DISPOSABLE AUTOMA SHERIDAN STAT-MED Cuffed Endotracheal Tube End Tidal CO2 Tube UroLift 2 ATC Advanced Tissue Control System, UL2 ATC Rusch Single Lumen Bronchial Tube TAUT BALLOON CATHETER HUDSON RCI LIFESAVER DISPOSABLE MANUAL RESUSCITATOR Hudson RCI Disposable PEEP Valve Gibeck RCI Disposable PEEP Valve RUSCH MANUAL RESUSCITATOR Raider guidewire Model Numbers: 7448 Raider Guidewire, 200cm and 7449 Raider Guidewire, 300cm Percuvance Percutaneous Surgical System Multiple oxygen analyzer/monitors MULTIPLE GASEOUS-PHAS Spectre guidewire Model Numbers: 7386 Spectre Guidewire, 200cm and 7387 Spectre Guidewire, 300cm QUAPAK Aquapak ConchaTherm LHF ConchaSmart Column Hudson RCI Neptune Heated Humidifier Comfort Flo Humidification System Percuvance GUARDIAN II NC HEMOSTASIS VALVE GUARDIAN II HEMOSTASIS VALVE QuikClot Hemostatic Dressings, QuikClot 2x2, QuikClot 4x4, QuikClot TraumaPad, QuikClot Z-Fold, QuikClot Roll ConchaTherm IV+ ConchaTherm IV ConchaTherm Brackets SHER-I-BRONCH ENDOBRONCHIAL TUBE Turnpike Catheter (135 cm),Turnpike Catheter (!50 cm),Turnpike Spiral Catheter (135 cm),Turnpike Spiral Catheter (150cm) Rusch Head Harness Hudson Mask Harness Hudson Head Harness Thermistor Probe Sheridan Laser-Trach SHERIDAN PED-SOFT UNCUFFED Endotracheal Tubes SHERIDAN EZ-ENDO Endotracheal Tube Sheridan Naz-al Endotracheal Tube Sheridan Uncuffed Endotracheal Tube SHERIDAN PREFORMED Endotracheal Tube Sheridan HVT Endotracheal Tube Sheridan LTS Endotracheal Tube Sheridan Close Fitting Endotracheal Tube Percuvance(TM) Percutaneous Surgical System Guideliner V3 Catheter Pronto LP Extraction Catheter. Model number 5010 - PRONTO LP 6F ConchaTherm III+ QuickClot Control+ Hemostatic Device Triflo SHERIDAN T.T.X. Exchanger SpyGlass Discover Imager II IOC Catheter Weck Auto Endo5 Hem-o-lok Ligating Clip Applier

    Establishment Types

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