Data / Medical devices / China / Eisungrain (Shandong) Eco Technology Co., Ltd.
Eisungrain (Shandong) Eco Technology Co., Ltd.: FDA-registered device maker in Zibo City Shandong, China, 1 510(k) clearance
Eisungrain (Shandong) Eco Technology Co., Ltd. is registered with the FDA (registration 3030516298) in Zibo City Shandong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030516298
- Address
- 5F/522 NO.179 Xincunxi Road, Xincheng Centre zhangdian, Zibo City Shandong, China, 255000
- Owner or operator
- Eisungrain(Shandong) Eco Technology Co., Ltd. (10089637)
- Roles
- Exporter to the US
- First device listed
- December 24, 2023
- Registered through
- 2026
- Brand names listed
- Disposable Sanitary Underpad (Nursing Pads), Female Incontinence Pants, Lady Pants, Menstrual Pants, Sanitary Liner Pads, Sanitary Napkins, Sanitary Liner Pads, Unscented Menstrual Pad, Viscose Tampon, Light and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US | 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 14, 2023 | K231341 | Organic cotton tampon, Viscose tampon | HEB | Substantially Equivalent | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2023. 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.