Data / Medical devices / China / Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.: FDA-registered device maker in Danyang Jiangsu, China, 12 510(k) clearances
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. is registered with the FDA (registration 3017825461) in Danyang Jiangsu, China. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 5, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017825461
- Address
- No.1 Baisheng Road Development Zone, Danyang Jiangsu, China, 212300
- Owner or operator
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (10084002)
- Roles
- Manufacturer
- First device listed
- January 7, 2022
- Registered through
- 2026
- Brand names listed
- Cardinal Health, Electronic Blood Pressure Monitor models YE620B,YE620D,YE660E,YE660F,YE680B, Electronic Blood Pressure Monitor models YE650A,YE650D,YE670A,YE670D,YE660B, Infrared ear thermometer YHT108,YHT202,YHT208, Infrared thermometer Model: YHW-6, REF: YHW-6001, YHW-6003, Infrared thermometer Model: YT-3, YHW-5, Inogen Voxi 5, MDSBPADVAN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | 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 5, 2026 | K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | DXN | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| February 23, 2026 | K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | DXN | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| February 17, 2026 | K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | DQA | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| June 5, 2025 | K242736 | Portable Oxygen Concentrator (Spirit-3) | CAW | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| May 22, 2025 | K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | FLL | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| April 28, 2023 | K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | CAW | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| October 17, 2022 | K221372 | YUWELL Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| August 16, 2022 | K212385 | YUWELL Finger Pulse Oximeter | DQA | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| May 20, 2021 | K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | FLL | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| December 7, 2020 | K201864 | YUWELL Infrared Thermometer | FLL | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| August 20, 2020 | K200939 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| March 27, 2018 | K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D | DXN | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Generator, Oxygen, Portable
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
- All makers of Clinical Electronic Thermometer
Updated March 5, 2026. 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.