Data / Medical devices / China / Nanjing Yinuoji Medical Technology Co., Ltd.
Nanjing Yinuoji Medical Technology Co., Ltd.: FDA-registered device maker in Nanjing Jiangsu, China, 2 510(k) clearances
Nanjing Yinuoji Medical Technology Co., Ltd. is registered with the FDA (registration 3037045878) in Nanjing Jiangsu, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3037045878
- Address
- 4th Floor, Building 8, Phase 6 Accelerator, No. 71 Xinghui Road, Jiangbei New Area, Nanjing Jiangsu, China, 210061
- Owner or operator
- Nanjing Yinuoji Medical Technology Co., Ltd. (10092892)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 4, 2025
- Registered through
- 2026
- Brand names listed
- WeOxy Q4 Portable Oxygen Concentrator, WeOxy Q5 Portable Oxygen Concentrator, WeOxy Q6 Portable Oxygen Concentrator, WeOxy Q7 Portable Oxygen Concentrator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 27, 2025 | K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | CAW | Substantially Equivalent | Nanjing Yinuoji Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 20, 2023 | K222920 | Oxygen concentrator | CAW | Substantially Equivalent | Zhengzhou Olive Electronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2025. 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.