Jiangsu Yuyue Medical Equipment & Supply Company Limited
Manufacturer and brand owner in Jiangsu, China. 17 device types, 9 products catalogued, 15 clearances.
Jiangsu Yuyue Medical Equipment & Supply Company Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Cane, Oximeter and 15 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2004.
17device types registered with the FDA
9products catalogued under its own name
15510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3004111085 |
| FEI number | 3004111085 |
| DUNS | 528704000 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 江苏鱼跃医疗设备股份有限公司 |
|---|---|
| Unified social credit code | 91321100703952657W |
| Source | NMPA UDI database |
Location
| City | Jiangsu |
|---|---|
| Province | Jiangsu |
| Address | YUNYANG INDUSTRIAL PARK |
| Postal code | 212300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Armrest, Wheelchair | Class 1 | Armrest | 2015 | 29 |
| Attachment, Commode, Wheelchair | Class 1 | 2016 | 70 | |
| Cane | Class 1 | Crutch models:YU860(Medium), YU860(Large), YU860(Extra large), YU861 | 2016 | 97 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class 1 | Cart | 2016 | 34 |
| Clinical Electronic Thermometer | Class 2 | Infrared thermometer Model: YHW-6, REF: YHW-6001, YHW-6003, Infrared ear thermometer YHT108,YHT202,YHT208, Infrared thermometer Model: YT-3, YHW-5 | 2025 | 49 |
| Components, Wheelchair | Class 1 | 2020 | 54 | |
| Continuous Measurement Thermometer | Class 2 | YUWELL® Infrared Ear Thermometer (YHT100), YUWELL® Infrared Ear Thermometer (YHT107), YUWELL Infrared Ear Thermometer models YHT101,YHT200, YUWELL Infrared Thermometer models YT-1,YT-1A,YT-1B,YT-1C,YT-2,YT-2A,YT-2B,YT-2C, Cardinal Health | 2022 | 115 |
| Cushion, Wheelchair | Class 1 | 2013 | 53 | |
| Footrest, Wheelchair | Class 1 | 2013 | 25 | |
| Generator, Oxygen, Portable | Class 2 | Oxygen Concentrator models 8F-3A,8F-5A, Inogen Voxi 5, Portable Oxygen Concentrator Spirit-3, Portable Oxygen Concentrator SP-3 | 2023 | 22 |
| Oximeter | Class 2 | Yuwell Finger Pulse Oximeter models YX102,YX103,YX301,YX306, YUWELL Finger Pulse Oximeter models YX105, YX106, YX110, YX310 | 2022 | 70 |
| Regulator, Pressure, Gas Cylinder | Class 1 | 2004 | 27 | |
| Stethoscope, Manual | Class 1 | 2016 | 64 | |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | YE680B PRO, YE660D Plus, Mdsbpadvan, Electronic Blood Pressure Monitor models YE620B,YE620D,YE660E,YE660F,YE680B, YE660D PRO, YE670A Plus and 6 more | 2022 | 98 |
| Table, Mechanical | Class 1 | 2006 | 46 | |
| Walker, Mechanical | Class 1 | 2016 | 183 | |
| Wheelchair, Mechanical | Class 1 | Wheelchair H035, Wheelchair H005, Wheechair PC008, Wheelchair K3, Wheelchair K4, Wheelchair K7 and 1 more | 2012 | 46 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Yuwell® Infrared Ear Thermometer | SDV | 8 |
| YUWELL®Finger Pulse Oximeter | DQA | 7 |
| Yuwell Electronic Blood Pressure Monitor | DXN | 4 |
| Electronic Blood Pressure Monitor | DXN | 2 |
| Yuwell Portable Oxygen Concentrator | CAW | 2 |
| Yuwell Oxygen Concentrator | CAW | 2 |
| Yuwell Infrared Thermometer | FLL | 1 |
| Inogen | CAW | 1 |
| Yuwell Infrared ear thermometer | FLL | 1 |
Clearances
15 clearances name Jiangsu Yuyue Medical Equipment & Supply Company Limited as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261571 | 2026-08-06 | IOR | Traditional | This company |
| K252779 | 2026-03-05 | DXN | Traditional | This company |
| K253228 | 2026-02-23 | DXN | Traditional | This company |
| K252805 | 2026-02-17 | DQA | Traditional | This company |
| K242736 | 2025-06-05 | CAW | Traditional | This company |
| K250878 | 2025-05-22 | FLL | Traditional | This company |
| K213825 | 2023-04-28 | CAW | Traditional | This company |
| K221372 | 2022-10-17 | DXN | Traditional | This company |
| K212385 | 2022-08-16 | DQA | Traditional | This company |
| K203583 | 2021-05-20 | FLL | Traditional | This company |
| K201864 | 2020-12-07 | FLL | Traditional | This company |
| K200939 | 2020-08-20 | DXN | Special | This company |
| K170605 | 2018-03-27 | DXN | Traditional | This company |
| K120526 | 2012-03-08 | IOR | Traditional | This company |
| K083559 | 2009-09-04 | CAW | Traditional | This company |
| K091482 | 2009-07-06 | IOR | Traditional | Danyang Huayi Medical Supply & Equipment Co., Ltd. |
| K080207 | 2008-03-12 | IOR | Traditional | Danyang Huayi Medical Supply & Equipment Co., Ltd. |
| K080114 | 2008-02-15 | IOR | Traditional | Danyang Huayi Medical Supply & Equipment Co., Ltd. |
| K002671 | 2000-10-11 | IOR | Traditional | Jiangsu Intco Medical Equipment & Supply Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 360 (Danyang facility) |
| Factory area | 31,000 square meters (Danyang facility) |
| Main products | Thermometers, Oxygen concentrators, Respiratory devices, Diabetes management solutions, Medical diagnostic devices |
| Export markets | Multiple countries globally |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | 31 |
| Suzhou Armocon Technology Co., Ltd. | 5 |
| Jiangsu Betterlife Medical Co., Ltd. | 4 |
| Viant Medical Suzhou EPZ Co., Ltd. | 3 |
| Kunshan Radiant Innovation Co., Ltd. | 2 |
| Jiangsu Jsongmed Medical Material Co., Ltd. | 2 |
| Jiangsu Dongbao Optical Co., Ltd. | 2 |
| Dynamic Connect (Suzhou) Hi-Tech Electronics Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.