Data / Medical devices / China / Shenzhen Yuezhongxing Technology Co.,ltd
Shenzhen Yuezhongxing Technology Co.,ltd: FDA-registered device maker in Huizhou Guangdong, China, 6 510(k) clearances
Shenzhen Yuezhongxing Technology Co.,ltd is registered with the FDA (registration 3017207990) in Huizhou Guangdong, China. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017207990
- Address
- 3 / F, Building 4, Kai Meng Zhigu Industrial Park, No. 463 Longshan 4th Road, Dayawan District, Huizhou Guangdong, China, 516081
- Owner or operator
- Shenzhen Yuezhongxing Technology Co.,Ltd (10082993)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- October 19, 2021
- Registered through
- 2026
- Brand names listed
- 333 Pulse Oximeter, Aleshon Fetal Doppler TK-T802CR.TK-T802R.TK-T802C.TK-T802.TK-T806CR.TK-T806R.TK-T806C.TK-T806, Aleshon Portable Mesh Nebulizer (Home-use) 506, 507, 508, Aleshon Ultrasonic Mesh Nebulizer 501/ 502/ 503 /504 /505, Aleshon, Finger Oximeter, Model 321, Aleshon, Finger Oximeter, Model 331, Aleshon, Finger Oximeter, Model 333, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Monitor, Ultrasonic, Fetal | KNG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2024 | K233799 | Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | DXN | Substantially Equivalent | Shenzhen Yuezhongxing Technology Co., Ltd. | accessdata.fda.gov |
| May 5, 2023 | K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | DXN | Substantially Equivalent | Shenzhen Yuezhongxing Technology Co., Ltd. | accessdata.fda.gov |
| January 7, 2022 | K211940 | Fetal Doppler | KNG | Substantially Equivalent | Shenzhen Taikang Medical Equipment Co., Ltd. | accessdata.fda.gov |
| August 30, 2021 | K211041 | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | DXN | Substantially Equivalent | Shenzhen Yuezhongxing Technology Co., Ltd. | accessdata.fda.gov |
| June 14, 2021 | K201397 | Ultrasonic Mesh Nebulizer | CAF | Substantially Equivalent | Shenzhen Ivankaca Technology Co., Ltd. | accessdata.fda.gov |
| December 30, 2020 | K202372 | Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Conmo Electronic Company Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Exerciser, Non-Measuring
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Irrigator, Powered Nasal
Updated March 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.