Data / Medical devices / Mexico / Welch Allyn De Mexico, S. De R.L. De C.V.

Welch Allyn De Mexico, S. De R.L. De C.V.: FDA-registered device maker in TIJUANA Baja California, Mexico, 1 510(k) clearance

Name: Welch Allyn De Mexico, S. De R.L. De C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Welch Allyn De Mexico, S. De R.L. De C.V. is registered with the FDA (registration 3006087789) in TIJUANA Baja California, Mexico. It lists 32 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 14, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006087789
Address: CALLE EMILIO FLORES 2471-A and 2469-C COL. CANON DEL PADRE, TIJUANA Baja California, Mexico, CO 22203
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 29, 1978
Registered through: 2026
Brand names listed: #156-3 & 156-4, 39000 series Blood Pressure Cuff, 719-3 Li-Ion Plus USB Handle for Desk Charger, 719-DSK Welch Allyn Universal Desk Charger, 719-USB USB POWER SUPPLY,5V,1.4A,USB-A, 767 Wall & Mobile Aneroids and Accessories, 790 Series Cordless Iluminator and wire Illuminator, 800 Series Cordless Illumination System and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Contract manufacturer	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Contract manufacturer	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Contract manufacturer	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Contract manufacturer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Contract manufacturer	accessdata.fda.gov
Continuous, Ventilator, Home Use	NOU	2	Contract manufacturer	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Contract manufacturer	accessdata.fda.gov
Device, Positive Pressure Breathing, Intermittent	NHJ	2	Contract manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Contract manufacturer	accessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)	MWJ	2	Contract manufacturer	accessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis Algorithm	MLO	2	Contract manufacturer	accessdata.fda.gov
Exerciser, Measuring	ISD	2	Contract manufacturer	accessdata.fda.gov
Exophthalmometer	HLS	1	Contract manufacturer	accessdata.fda.gov
Holder, Ear Speculum	JYK	1	Contract manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Contract manufacturer	accessdata.fda.gov
Light, Headband, Surgical	FSR	2	Contract manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Contract manufacturer	accessdata.fda.gov
Ophthalmoscope, Ac-Powered	HLI	2	Contract manufacturer	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Contract manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Contract manufacturer	accessdata.fda.gov
Percussor, Powered-Electric	BYI	2	Contract manufacturer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Contract manufacturer	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Contract manufacturer	accessdata.fda.gov
Retinoscope, Battery-Powered	HKM	1	Contract manufacturer	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Contract manufacturer	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Contract manufacturer	accessdata.fda.gov
Stand, Instrument, Ophthalmic, Battery Powered	NOI	1	Contract manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Test-Pattern, Radiographic	IXF	1	Contract manufacturer	accessdata.fda.gov
Transilluminator, Battery-Powered	HJN	1	Contract manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Contract 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
October 14, 2016	K161886	Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 14, 2016. 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.