SHENZHEN HOMED MEDICAL DEVICE CO LTD

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3013000203

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013000203
FEI Number
3013000203
Entity Name
SHENZHEN HOMED MEDICAL DEVICE CO LTD
City/State/Country
Dongguan Guangdong, CN
Establishment Address
Block 5, 2 Anyue Road, Chashan Town,Dongguan City 523393, Guangdong Province, People's Republic of China, Dongguan Guangdong 523393, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
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
N
Expiration Date (Year)
2026
510(k) Number
K020932
PMA Number
N/A

All Registered Proprietary Names

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) BYX - TUBING, PRESSURE AND ACCESSORIES GAZ - TUBING, NONINVASIVE FILTER Nasal spray, ENT dclivery mouthpiece Nebulizer Nebulizer ,JLN-S07(6910P) Ventilator Tube,HMV—VP01,HMV—VP02 Nebulizer Compressor Nebulizer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2017-12-25
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2024-01-26
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2026-06-09
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2024-01-26
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2012-09-23
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2025-05-16
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2024-11-04
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-09
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2020-07-12
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2020-10-20
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

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
3010287621 SHENZHEN HOMED MEDICAL DEVICE CO LTD Shenzhen city Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
K910471 Baxter Healthcare Corp MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE 1991-03-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2026 Percussionaire Corporation 1
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013000203. Last updated year: 2026. Please use registration number 3013000203 when referencing this establishment in official correspondence.
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