Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008220943

FEI Number

3008220943

Entity Name

FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Foshan Guangdong, CN

Establishment Address

#2 Haitang Rd, National Ecological Industrial Park, Danzao, Town, Nanhai District, Foshan Guangdong 528000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Foshan Care Medical Technology Co., Ltd. (Owner Number: 10036239)

Owner / Operator Contact Address

#2 Haitang Rd, National Ecological Industrial Park, Danzao Town, Nanhai District, Foshan, CN-GD 528000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102245

PMA Number

N/A

All Registered Proprietary Names

Oxygen Concentrator (ZY-10AB/115) KYWH2001 KYWH2004 KYWH2006 Care Nebulizer SU01A CARE ZY5BA Oxygen Concentrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2024-12-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-04-25
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2014-06-30
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2011-05-10

Official Correspondent

Relly Cheng

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Foshan Care Medical Technology Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

Similar Registrations

Registration Number	Establishment Name	Location
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3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008220943. Last updated year: 2026. Please use registration number 3008220943 when referencing this establishment in official correspondence.