Data / Medical devices / Mexico / Westmed de Mexico, S.A de C.V

Westmed de Mexico, S.A de C.V: FDA-registered device maker in NOGALES Sonora, Mexico, 1 510(k) clearance

Name: Westmed de Mexico, S.A de C.V FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Westmed de Mexico, S.A de C.V is registered with the FDA (registration 3006606984) in NOGALES Sonora, Mexico. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 25, 1980. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006606984
Address: Avenida El Castillo 17-B, NOGALES Sonora, Mexico, 84094
Owner or operator: SunMed Group Holdings, LLC dba AirLife (10044795)
Roles: Contract manufacturer, Manufacturer
First device listed: August 2, 2013
Registered through: 2027
Brand names listed: AMBU CO2 Easy, AMBU Pedi CO2 Easy, APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED, Adapter Trach T, AirLife Bubble Humidifier, AirLife GSL, Airlife Nebulizer, Ballard Metered Dose Inhaler (MDI) Adapter and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Contract manufacturer	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Contract manufacturer	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Contract manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Contract manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Contract manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Contract manufacturer	accessdata.fda.gov
Humidifier Nebulizer Kit	OGG	2	Contract manufacturer	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Contract manufacturer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Contract manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Contract manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer	accessdata.fda.gov
Support, Breathing Tube	JAY	1	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	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
March 25, 1980	K800562	DISPOSABLE HAND HELD NEBULIZER	CAF	Substantially Equivalent	Intec Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 25, 1980. 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.