Data / Medical devices / China / Shandong Intco Hygiene Products Co., Ltd.
Shandong Intco Hygiene Products Co., Ltd.: FDA-registered device maker in Zibo Shandong, China, 2 510(k) clearances
Shandong Intco Hygiene Products Co., Ltd. is registered with the FDA (registration 3026199504) in Zibo Shandong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026199504
- Address
- Workshop C3, No. 29, Zhangliu Road, Fangzhen Town Zhangdian District, Zibo Shandong, China, 255095
- Owner or operator
- Shandong Intco hygiene Products Co., Ltd. (10086734)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 6, 2022
- Registered through
- 2026
- Brand names listed
- CARDBOARD APPLICATOR TAMPON, Pad, menstrual, unscented, Tampon unscented, Unscented Tampon, Unscented Tampon with Plastic Applicators
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 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 |
|---|---|---|---|---|---|---|
| January 10, 2025 | K241064 | Unscented Tampon | HEB | Substantially Equivalent | Shandong Intco Hygiene Products Co., Ltd. | accessdata.fda.gov |
| February 13, 2020 | K192557 | Youjia Unscented Tampon with Plastic Applicators | HEB | Substantially Equivalent | Qingdao Youjia Hygiene Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 10, 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.