Shenzhen Changkun Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 11 device types, 10 products catalogued, 7 clearances.
Shenzhen Changkun Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Thermometer Kit and 9 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
11device types registered with the FDA
10products catalogued under its own name
7510(k) clearances
Registration
| Registered name | SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009617411 |
| FEI number | 3009617411 |
| DUNS | 554502671 |
| Establishment type | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市长坤科技有限公司 |
|---|---|
| Unified social credit code | 91440300685360614P |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community |
| Postal code | 518118 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer, Models: CK-T1501, CK-T1502, CK-T1503, CK-T1803, CK-T1805, CK-T1806, CK-T1905, CK-T1906, CK-T2009 | 2020 | 115 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | Hearing Aid, Air-Conduction, Prescription D8, D9 | 2021 | 45 |
| Irrigator, Powered Nasal | Class 1 | NASAL IRRIGATOR models XB-2201, XB-2202, XB-2203 | 2023 | 63 |
| Massager, Therapeutic, Electric | Class 1 | Massager, therapeutic, electric HQ-365, HQ-366, HQ-367, HQ-368, HQ-369, HQ-310, HQ-311,JY-203,JY-008,M078,EB01 | 2021 | 437 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Mesh Nebulizer CK-AT018 , CK-AT019 | 2025 | 57 |
| Oximeter | Class 2 | Finger Pulse Oximeter Model: X1906P,X1805,X1805P,X1906,X1907,X1907P,X1908,X1908P,X1909,X1909P | 2023 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | oximeter,infrared,sporting,aviation with models X1805/X1805P/X1906/X1906P/X1907/X1907P/X1908/X1908P | 2024 | 29 |
| Pump, Breast, Powered | Class 2 | 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, Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | 2023 | 40 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | Class 2 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | 2026 | 7 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 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-A1916P, CK-A2006, CK-A2008, X180, CK-A158, CK-A168, Arm Electronic Sphygmomanometer /Arm Blood Pressure Monitor, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A156, 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-W175, CK-W176, CK-W355, CK-W356, CK-W358, Wrist Electronic Sphygmomanometer /Wrist lithium-ion blood pressure monitor,Models: CK-W359,CK-W360 and 3 more | 2021 | 98 |
| Thermometer Kit | Class 2 | Thermometer kit CK-T1501, CK-T1502, CK-T1503 | 2020 | 11 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Mbupai | DXN | 4 |
| Coverich | DXN | 3 |
| Nouyan | DXN | 2 |
| Mmizoo | DXN | 1 |
| Figaroo™ Dash | HGX | 1 |
| Figaroo™ Endura | HGX | 1 |
| Peakme | DXN | 1 |
| maguja | DXN | 1 |
| Handy Solutions | FLL | 1 |
| Wishlove | DXN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250070 | 2026-06-26 | HGX | Traditional | This company |
| K252552 | 2026-05-06 | KPI | Traditional | This company |
| K231595 | 2023-10-26 | HGX | Traditional | This company |
| K221798 | 2023-05-04 | DQA | Traditional | This company |
| K193386 | 2021-01-27 | DXN | Traditional | This company |
| K193387 | 2021-01-27 | DXN | Traditional | This company |
| K193253 | 2020-06-17 | FLL | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Main products | Blood pressure meters, Thermometers, Medical devices |
| Certifications | FDA, CE, RoHS, ISO13485, CFDA |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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