Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030647

FEI Number

3014611165

Entity Name

Westmed de Mexico, S.A de C.V

City/State/Country

MAGDALENA Sonora, MX

Establishment Address

CARRETERA INTERNACIONAL, SALIDA NORTE No. 1053, MAGDALENA Sonora CP 84160, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SunMed Group Holdings, LLC dba AirLife (Owner Number: 10044795)

Owner / Operator Contact Address

2710 Northridge Drive NW, Suite A, Grand Rapids, MI 49544, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CATHETER AND TIP, SUCTION Water Solutions Saline And Sterile Ballard Metered Dose Inhaler (MDI) Adapter CATHETERS, SUCTION, TRACHEOBRONCHIAL Ballard Single Dose Vials, 0.9% Sodium Chloride Solution PERCUSSOR TOOTHBRUSH, MANUAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-07-18
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-07-18
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2024-11-01
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-11-01

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

SunMed Group Holdings, LLC dba AirLife

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010362947	Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, CN
3030308442	SUNMED GROUP HOLDINGS, LLC dba AirLife	Litchfield Park, AZ, US
3006606984	Westmed de Mexico, S.A de C.V	NOGALES Sonora, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
3010838917	AirLife Finland Oy	Helsinki Uusimaa, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030647. Last updated year: 2026. Please use registration number 8030647 when referencing this establishment in official correspondence.