BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN HOMED MEDICAL DEVICE CO LTD

    Reg #: 3013000203 · FEI: 3013000203 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    SHENZHEN HOMED MEDICAL DEVICE CO LTD
    Registration Number
    3013000203
    FEI Number
    3013000203
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Block 5, 2 Anyue Road, Chashan Town,Dongguan City 523393, Guangdong Province, People's Republic of China
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150591

    Owner / Operator

    Firm Name
    Shenzhen Homed Medical Device Co., Ltd
    Operator Number
    10041952
    Address
    Room1601to1614,ABuilding,JinxiuIII,No.85HudiPaiSongxuanCommunity,GuanhuStreet,Longhua District,Shenzhen, Shenzhen City Guangdong, CHINA 518109
    City
    shenzhen
    State
    Guangdong
    Postal Code
    518109
    Country
    CN
    Correspondent
    Shengming Shi

    US Agent

    Business Name
    CTI US lnc.
    Contact Name
    Robin Zhang
    Address
    1455 Lincoln Pkwy E Ste 230
    City
    Atlanta
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    313 2885666

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Tubing, Pressure And Accessories BYX
    Sleeve, Limb, Compressible JOW
    Tubing, Noninvasive GAZ
    Unit, Filter, Membrane JRL
    Nasal Spray, Ent Delivery KCO
    Mouthpiece, Breathing BYP
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Compressor, Air, Portable BTI
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Cannula, Nasal, Oxygen CAT
    Mask, Oxygen BYG
    Generator, Oxygen, Portable CAW

    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 Compressor Nebulizer Mesh Nebulizer-JLN-MB001,JLN-MB002,JLN-MB003,JLN-MB004,JLN-MB005,JLN-MB006,JLN-MB007 Curelief Purabreathe Mesh Nebulizer Mesh Nebulizer- UN200 Suction Cannister kit nasal oxygen cannula Nebulizer-JLI Nebulizer-JLM,JLK,JLH,JLD mask Portable Oxygen Generator,JLO-190P,JLO-190PL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device