Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010287621

FEI Number

3010287621

Entity Name

SHENZHEN HOMED MEDICAL DEVICE CO LTD

City/State/Country

Shenzhen city Guangdong, CN

Establishment Address

Room 1601-1614, A Building , Jinxiu III, No.85 Hudi Pai, Songxuan Community, Guanhu Street, Longhua District, Shenzhen city Guangdong 518109, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Shenzhen Homed Medical Device Co., Ltd (Owner Number: 10041952)

Owner / Operator Contact Address

Room1601to1614,ABuilding,JinxiuIII,No.85HudiPaiSongxuanCommunity,GuanhuStreet,Longhua District,Shenzhen, Shenzhen City Guangdong, CHINA 518109, shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nebulizer ,JLN-S07(6910P) BYX - TUBING, PRESSURE AND ACCESSORIES mask mouthpiece Portable Oxygen Generator,JLO-190P,JLO-190PL Suction Cannister kit Nebulizer Compressor Nebulizer Nebulizer MQ5900,MQ5900P Piston Compress Nebulizer -JLN-2312AS(MQ6002), JLN-2313AS(18070), JLN-2318AS(18080), JLN-2337AS(MQ5600) Piston Compress Nebulizer - JLN-2317AS(MQ5800), JLN-2320AS,JLN-2305BS-B(MQ6000),JLN-2305BS,JLN-2322AS Piston Compress Nebulizer -JLN-2319AS, JLN-2342AS(MQ6005),JLN-2300AS,JLN-2301AS,JLN-2309AS,JLN-2360AS Piston Compress Nebulizer -JLN-2341AS(MQ6003), JLN-2343AS(18090-BE),JLN-2310AS(18090-FS), JLN-2308AS(3050-2) Piston Compress Nebulizer - JLN-2300Air, JLN-2305AS, JLN-2302AS, JLN-2300BS, JLN-2315AS,JLN-2362AS,JLN-2311HD JLN-2308AS(3050-3NDS) Piston Compressor Nebulizer-JLN-2301HD Piston Compress Nebulizer - JLN-2305HD Piston Compress Nebulizer-JLN-2318Air,JLN-2361Air JLN-2308AS(3050-2NDS) Piston Compress Nebulizer-570-5616(JLN-2318AS) GAZ - TUBING, NONINVASIVE Nasal spray, ENT dclivery

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2020-07-12
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-01-26
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-01-29
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-11-04
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2026-02-04
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-06-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-01-14
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2019-01-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-12-25
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-01-26
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2025-05-16

Official Correspondent

Shengming Shi

US Agent Details

Robin Zhang Business: CTI US lnc. Email: robin.zhang@cti-cert.com Phone: (313) 2885666

Related Public Records

Same Entity

Shenzhen Homed Medical Device Co., Ltd

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013000203	SHENZHEN HOMED MEDICAL DEVICE CO LTD	Dongguan Guangdong, CN

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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

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-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010287621. Last updated year: 2026. Please use registration number 3010287621 when referencing this establishment in official correspondence.