Nanjing Yinuoji Medical Technology Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3037045878
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Nanjing Yinuoji Medical Technology Co., Ltd. makes
Nanjing Yinuoji Medical Technology Co., Ltd. manufactures portable oxygen concentrators, including models such as the W-R1(MAX), W-R1, W-R2, and W-R2(Lite). These devices are designed to provide continuous or pulse-dose oxygen therapy for patients requiring supplemental oxygen outside of clinical settings.
The company’s portable oxygen concentrators are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3037045878
- Address
- 4th Floor, Building 8, Phase 6 Accelerator, No. 71 Xinghui Road, Jiangbei New Area, Nanjing Jiangsu
Frequently asked questions
How many devices does Nanjing Yinuoji Medical Technology Co., Ltd. have in the registry?
The registry currently lists 1 device for Nanjing Yinuoji Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nanjing Yinuoji Medical Technology Co., Ltd.'s devices?
Among its 1 most recently registered device, Nanjing Yinuoji Medical Technology Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Nanjing Yinuoji Medical Technology Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Nanjing Yinuoji Medical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nanjing Yinuoji Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Nanjing Yinuoji Medical Technology Co., Ltd. include Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)).