Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006087789

FEI Number

3006087789

Entity Name

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

City/State/Country

TIJUANA Baja California, MX

Establishment Address

CALLE EMILIO FLORES 2471-A and 2469-C, COL. CANON DEL PADRE, TIJUANA Baja California CO 22203, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 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 Accessories 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2022-01-10
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-01-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-01-10
NOI	Stand, Instrument, Ophthalmic, Battery Powered	Ophthalmic	Class 1	886.1860	2022-01-11
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2023-07-17
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2023-10-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-01-11
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-01-10
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-02-16
FSR	Light, Headband, Surgical	Ophthalmic	Class 2	886.4335	2023-09-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-01-11
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2022-01-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-01-11
HJN	Transilluminator, Battery-Powered	Ophthalmic	Class 1	886.1945	2022-01-11
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2022-01-10
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2022-01-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-01-10
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-01-10
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2022-01-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-01-10
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2022-01-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-01-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-01-11
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	2022-01-11
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2023-10-11
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2022-01-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-01-10
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2023-09-19
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-01-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-07-25
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2025-12-17
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2024-07-25
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-01-11
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2024-04-18
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	1978-12-29
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	2024-07-22

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Similar Registrations

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
1527715	SCOTTCARE CORPORATION	CLEVELAND, OH, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3030721635	ICENTIA LLC	Burlington, VT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006087789. Last updated year: 2026. Please use registration number 3006087789 when referencing this establishment in official correspondence.