Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010362947

FEI Number

3010362947

Entity Name

Shenzhen Vital Signs-KTL Medical Instrument Co Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 3, NO.88 North Jiaoyu Road, Gaoqiao Industrial Park, Pingdi, Longgang District, Shenzhen Guangdong 518117, CN

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

Vent Mask II Breath Tech Mask Soft-Aire Mask Vent Mask Westmed Anesthesia Masks MASK, GAS, ANESTHETIC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-01-17

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
3030308442	SUNMED GROUP HOLDINGS, LLC dba AirLife	Litchfield Park, AZ, US
8030647	Westmed de Mexico, S.A de C.V	MAGDALENA Sonora, MX
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

Similar Registrations

Registration Number	Establishment Name	Location
2028807	WESTMED, INC.	TUCSON, AZ, US
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3005977696	MEDICAL DEVELOPMENTS INTERNATIONAL	Scoresby Victoria, AU
3015665020	GUANGZHOU SHENGWEI MEDICAL DEVICES CO., LTD.	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010362947. Last updated year: 2026. Please use registration number 3010362947 when referencing this establishment in official correspondence.