SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3009617411

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
3009617411
FEI Number
3009617411
Entity Name
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District,, Shenzhen Guangdong 518118, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Shenzhen Changkun Technology Co., Ltd. (Owner Number: 10071297)
Owner / Operator Contact Address
101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District, Shenzhen, CN-GD 518118, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMA Irrigator, Powered Nasal Ear, Nose, Throat Class 1 874.5550 2023-12-18
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2024-04-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-03-29
ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat Class 1 874.3300 2021-04-27
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2021-05-25
PXH Thermometer Kit General Hospital Class 2 880.2910 2020-04-21
KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology Class 2 876.5320 2026-05-17
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2023-11-13

Official Correspondent

Qingpeng Wang

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Shenzhen Changkun 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
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number Establishment Name Location
2032685 HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP. LOS ANGELES, CA, US
3013257234 MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD Dongguan Guangdong, CN
3015277818 HANGZHOU WEIZE IMP & EXP CO., LTD Hangzhou Zhejiang, CN
3042277519 CHANGZHOU SAISHENG MEDICAL TECHNOLOGY CO., LTD Changzhou Jiangsu, CN
3018975080 SHENZHEN MICRO ELECTRIC INTELLIGENCE CO., LTD. Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009617411. Last updated year: 2026. Please use registration number 3009617411 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.