BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.

    Reg #: 3009617411 · FEI: 3009617411 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    20
    Establishment Types
    4
    Classifications
    11

    Registration Details

    Registration Name
    SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
    Registration Number
    3009617411
    FEI Number
    3009617411
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District,
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K193387

    Owner / Operator

    Firm Name
    Shenzhen Changkun Technology Co., Ltd.
    Operator Number
    10071297
    Address
    101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518118
    Country
    CN
    Correspondent
    Qingpeng Wang

    US Agent

    Business Name
    SUN LUNA STAR LLC
    Contact Name
    Anna Sun
    Address
    6706 N Royce Ln
    City
    Van Nuys
    State
    CA
    ZIP
    91411
    Country
    US
    Email
    [email protected]
    Phone
    626 2005096

    Products

    Device Name Product Code
    Irrigator, Powered Nasal KMA
    Oximeter, Infrared, Sporting, Aviation OCH
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Hearing Aid, Air-Conduction, Prescription ESD
    Massager, Therapeutic, Electric ISA
    Thermometer Kit PXH
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Pump, Breast, Powered HGX
    Oximeter DQA
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Continuous Measurement Thermometer FLL

    Proprietary Names

    NASAL IRRIGATOR models XB-2201, XB-2202, XB-2203 oximeter,infrared,sporting,aviation with models X1805/X1805P/X1906/X1906P/X1907/X1907P/X1908/X1908P Arm Electronic Sphygmomanometer/Arm Blood Pressure Monitor, Models: CK-A159, CK-A1912, CK-A1915, CK-A1915P, CK-A1916 Arm Electronic Sphygmomanometer /Arm Blood Pressure Monitor, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A156 Arm Electronic Sphygmomanometer/Arm Blood Pressure Monitor, Models:CK-A1916P, CK-A2006, CK-A2008, X180, CK-A158, CK-A168 Hearing Aid, Air-Conduction, Prescription D8, D9 Massager, therapeutic, electric HQ-365, HQ-366, HQ-367, HQ-368, HQ-369, HQ-310, HQ-311,JY-203,JY-008,M078,EB01 Thermometer kit CK-T1501, CK-T1502, CK-T1503 Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) Electric breast pump with models MY-371,MY-372,MY-373,MY-374,MY-375,MY-376,MY-378,MY-379,MY-380, V3 Electric breast pump with models MY-381,MY-382,MY-383,MY-384,MY-385,MY-386,MY-387,MY-388,MY-389,MY-390 Finger Pulse Oximeter Model: X1906P,X1805,X1805P,X1906,X1907,X1907P,X1908,X1908P,X1909,X1909P Mesh Nebulizer CK-AT018 , CK-AT019 Infrared Thermometer, Models: CK-T1501, CK-T1502, CK-T1503, CK-T1803, CK-T1805, CK-T1806, CK-T1905, CK-T1906, CK-T2009 Wrist Electronic Sphygmomanometer /Wrist Blood Pressure Monitor , Models: CK-W182, CK-W185, K201, CK-W198, CK-W199 Wrist Electronic Sphygmomanometer /Wrist Blood Pressure Monitor, Models: CK-W133, CK-W135, W1681 Wrist Electronic Sphygmomanometer /Wrist Blood Pressure Monitor, Models: CK-W175, CK-W176, CK-W355, CK-W356, CK-W358 Wrist Electronic Sphygmomanometer /Wrist Blood Pressure Monitor , Models: CK-101, CK-101S, CK-102S, CK-W118, CK-W132 Wrist Electronic Sphygmomanometer /Wrist lithium-ion blood pressure monitor,Models: CK-W359,CK-W360 Wrist Electronic Sphygmomanometer /Wrist lithium-ion blood pressure monitor,Models: CK-W133,CK-W175,CK-W176,CK-W358

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device