BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V.

    Reg #: 3006087789 · FEI: 3006087789 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    140
    Establishment Types
    3
    Classifications
    33

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    Registration Details

    Registration Name
    WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V.
    Registration Number
    3006087789
    FEI Number
    3006087789
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CALLE EMILIO FLORES 2471-A and 2469-C, COL. CANON DEL PADRE
    City
    TIJUANA Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K161886

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    US Agent

    Business Name
    BAXTER HEALTHCARE CORPORATION
    Contact Name
    Maha Nolasco
    Address
    25212 W. IL Route 120, RLT-04
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2706181

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Electrocardiograph DPS
    Stand, Instrument, Ophthalmic, Battery Powered NOI
    Ophthalmoscope, Ac-Powered HLI
    Camera, Ophthalmic, Ac-Powered HKI
    Blood Pressure Cuff DXQ
    Clinical Electronic Thermometer SDV
    Light, Headband, Surgical FSR
    Otoscope ERA
    Transilluminator, Battery-Powered HJN
    Device, Medical Examination, Ac Powered KZF
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Computer, Diagnostic, Programmable DQK
    Device, Positive Pressure Breathing, Intermittent NHJ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Retinoscope, Battery-Powered HKM
    Ophthalmoscope, Battery-Powered HLJ
    Spirometer, Diagnostic BZG
    Speculum, Vaginal, Nonmetal HIB
    Exerciser, Measuring ISD
    Percussor, Powered-Electric BYI
    Laryngoscope, Rigid CCW
    Holder, Ear Speculum JYK
    Compressor, Air, Portable BTI
    Continuous, Ventilator, Home Use NOU
    Ventilator, Continuous, Facility Use CBK
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Refractometer, Ophthalmic HKO
    Exophthalmometer HLS
    Camera, Ophthalmic, General-Use PJZ
    Test-Pattern, Radiographic IXF
    Stand, Instrument, Ac-Powered, Ophthalmic HMF

    Proprietary Names

    H12+ Holter Recorder Surveyor Review Surveyor Central Surveyor Central Station Burdick ELI 230 /BUR 230 Electrocardiograph ELI 230/ELI 230 Electrocardiograph/ ELI 230 Cardiograph Welch Allyn Universal Desk Charger with Lithium-ion Handles 719-USB USB POWER SUPPLY,5V,1.4A,USB-A 719-3 Li-Ion Plus USB Handle for Desk Charger 719-DSK Welch Allyn Universal Desk Charger Ophthalmoscope and Accessories Pocket LED Ophthalmoscope Pocket Scope Ophthalmoscope iExaminer system with Panoptic Plus Sphygmomanometers Bronze Series - DS44, DS54 Aneroids and accessories Gold Series - DS56, DS66 Aneroids and accessorie Durashock Sphygmomanometers and accessories Blood Pressure Cuff- Durashock Sphygmomanometers multiple and Accessories Silver Series - DS45, DS55, DS65 Aneroids and accessories Platinum Series - DS58, DS48, DS48A Aneroids and accessories Quinton CR60/TM65 Treadmill X-Scribe / XScribe Stress Exercise Testing System Quinton Q-Stress Stress Exercise Testing System SureTemp Plus Probes and Probe Covers; Electronic Thermometry BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE Battery Door (EU) Pro6000 Bulk Pack 4th ed SureTemp Plus Electronic Thermometers (690 & 692 Series) and Accessories Thermometer Avita 410671 Care Temp Touch Free Thermometer Accessories 901094 Non Contact Thermometer PRO6000 Small Cradle & Charge Doc EU Thermometer, electronic, clinical Thermometer with Charge Dock; 6' Tether for PRO 6000 Care Temp Touch Free Thermometer #105801 Thermometer Charge Dock Only Braun Thermoscan Pro 6000 Battery Door (US) Therm w/ large cradle 4th ed Them w/ large cradle PRO6000 Bulk Pack Probe Covers 9' Tether for PRO6000 PRO6000 Small Cradle PRO6000 Large Cradle Rechargeable Battery PRO6000 PRO6000 Charge Station (US) Green Series Portable Headlights - Solid State Portable Headlight and accessories Omni cuffs and accessories Blood Pressure Cuffs- Balanced Nylon Bladders and accessories Digital MacroView, MacroView, 3.5V Diagnostic, Pneumatic, Op77E-Rating, PocketScope, Pocket Jr. Welch Allyn MacroView Plus Oto for iEx Welch Allyn MacroView Plus iExaminer Kit Welch Allyn LumiView Clear Single-Use Ear Specula Pocket LED Otoscopes (multi-colors) and accessories Welch Allyn LED Otoscope Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories Welch Allyn MacroView Basic Otoscope Reusable and Disposable Specula,Dispensers Otoscope and Accessories BLK Pocket LED Otoscope Trimline Blood Pressure Cuffs & Disposable Tempa-Kuffs Blood Pressure Cuff Accessories 39000 series Blood Pressure Cuff Trimline Universal Connectivity Kit Batter Powered Transilluminator - Fiber Optic Transilluminators and accessories TruLight 1000 Examination Light and accessories [Baxter] Green Series Exam Lights (Light IV, 300, 600, 900) and Accessories [a Welch Allyn, Inc. Tijuana Product] H3+ Holter Recorder CardioConfirm Metaneb ELI 250c / ELI 250Rx Electrocardiograph Burdick ELI 250c/Burdick 250c Electrocardiograph BUR 250c Volara System Synclara Cough System Maximus System Optimus ProBP2000-A ProBP2000-P ProBP2000 Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device Blood Pressure Cuffs- Omni-Kuff and accessories Battery Powered Retinoscope Devices - Elite Streak and Spot Retinoscopes Ophthalmoscope, battery-powered Welch Allyn Diagnostic Cardiology Suite Welch Allyn Diagnostic Cardiology Suite - Spirometry 901128 CARDIOPULMONARY ECG SYSTEM Welch Allyn Diagnostic Cardiology Suite - ECG 800 Series Cordless Illumination System Obstetric-gynecologic Specialized Manual Instrument - KleenSpec Single Use Vaginal Speculum 790 Series Cordless Iluminator and wire Illuminator KleenSpec Disposable Vaginal Speculum and accessories ELI 380 Electrocardiograph / ELI 380 / ELI 380 Cardiograph ELI 380 ERGO TANGO M2 BLOOD PRESSURE MONITOR Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) ERGOSELECT 100 K/P, ERGOSELECT 200 K/P Reusable One-piece, Soft Disposable One-Piece, Vinyl Disposable One-Piece and accessories Flexiport Blood Pressure Cuffs and accessories The Vest APX System Rigid Laryngoscope - Fiber Optic Laryngoscopes, standard laryngoscope and accessories Dispenser for 524 Series Disposable Ear Spec Life2000 Ventilation System H-Scribe 5 Holter Analysis system Hscribe Holter Analysis System H-Scribe Holter Analysis System Spot Vision Screener (901029) VS100 Vision Screener (901029) Ophthalmic Refractometer Devices - Spot VS100 and SureSight Series and accessories Metaneb 4 Connex Cardio R-Scribe Electrocardiograph Universal Desk Charger for Lithium Ion and NiCad Handles, P/N 71110, 71140 Series Accessories - Ophthalmoscope (e.g., PanOptic, etc.) and Otoscope (e.g., MacroView, etc.) Burdick ELI 280/BUR 280 Electrocardiograph McKesson Lumeon Series Burdick ELI 280 ELI 280 Electrocardiograph / ELI 280 Cardiograph T-H-BP100SBP H-BP100SBP RPM-BP100 ELI 150Rx / ELI 150RX / ELI 150c / ELI 150c Rx Electrocardiograph / ELI 150c Cardiograph Burdick ELI 150c/BUR 150c Electrocardiograph McKesson Lumeon Series Burdick ELI 150c i-Examiner (Panoptic Ophthalmosope and iPhone) and Accessories RV700 RV100 Pro RV100 RetinaVue 700 Imager Eye-Fundus Camera - RetinaVue 100 Imager Spot Vision Screener iExaminer Resolution Test Card - for OTOSCOPE Two-Piece Blood Pressure Cuffs and accessories Tycos 509 Wall and Mobile Aneroids and accessories 767 Wall & Mobile Aneroids and Accessories Service Parts Only One-Piece Disposable Neonate Blood Pressure Cuffs and accessories AC Powered Instrument Stand - 777 Wall Transformer AC Powered Instrument Stand - 777 Wall Transformer Set (including Otoscopes, Ophthalmoscope) and accessories #156-3 & 156-4

    Establishment Types

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