Data / Medical devices / China / Jiangxi Yikang Medical Instrument Group Co., Ltd.
Jiangxi Yikang Medical Instrument Group Co., Ltd.: FDA-registered device maker in Nanchang Jiangxi, China, 2 510(k) clearances
Jiangxi Yikang Medical Instrument Group Co., Ltd. is registered with the FDA (registration 3013002100) in Nanchang Jiangxi, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 6, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013002100
- Address
- No.188 LiduAihua Ave., Jinxian County, Nanchang Jiangxi, China, 331725
- Owner or operator
- Jiangxi Yikang Medical Instrument Group Co., LTD. (10051716)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 13, 2018
- Registered through
- 2026
- Brand names listed
- Endotracheal Tube, Latex Foley Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 6, 2019 | K190213 | Yikang Endotracheal Tube | BTR | Substantially Equivalent | Jiangxi Yikang Medical Instrument Group Co., Ltd. | accessdata.fda.gov |
| July 13, 2018 | K173340 | Yikang Latex Foley Catheter | EZL | Substantially Equivalent | Jiangxi Yikang Medical Instrument Group Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 6, 2019. 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.