Data / Medical devices / China / Yadu Medical (henan) Co., Ltd
Yadu Medical (henan) Co., Ltd: FDA-registered device maker in Changyuan Henan, China, 3 510(k) clearances
Yadu Medical (henan) Co., Ltd is registered with the FDA (registration 3034629649) in Changyuan Henan, China. It lists 30 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 7, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3034629649
- Address
- No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE'S REPUBLIC OF CHINA, Changyuan Henan, China, 453400
- Owner or operator
- YADU Medical (Henan) Co., Ltd (10092032)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 26, 2024
- Registered through
- 2027
- Brand names listed
- Absorbent Cotton Wool, Adult diaper, Adult pad, Applicator, Absorbent Tipped, Sterile, Apron, Baby diaper, Baby pad, Bed Sheet and more
Devices it lists
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 7, 2026 | K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | FYA | Substantially Equivalent | Yadu Medical (Henan) Co., Ltd. | accessdata.fda.gov |
| February 4, 2026 | K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | FYA | Substantially Equivalent | Yadu Medical (Henan) Co., Ltd. | accessdata.fda.gov |
| December 3, 2025 | K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | FYA | Substantially Equivalent | Yadu Medical (Henan) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Non-Surgical Gown
- All makers of Catheter And Tip, Suction
- All makers of Bedding, Disposable, Medical
- All makers of Cannula, Nasal, Oxygen
- All makers of Brush, Scrub, Operating-Room
Updated August 7, 2026. 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.