Yadu Medical (Henan) Co., Ltd
Changyuan Henan, CN
YADU MEDICAL (HENAN) CO., LTD appears in FDA device records in Changyuan Henan, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Yadu Medical (Henan) Co., Ltd between 2025 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | FYA | Substantially Equivalent | |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | FYA | Substantially Equivalent | |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | FYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3034629649 | 3034629649 | YADU MEDICAL (HENAN) CO., LTD | No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE'S REPUBLIC OF CHINA, Changyuan Henan 453400 CN | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- IWOApron, Protective
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- NECBandage, Liquid, Skin Protectant
- KMEBedding, Disposable, Medical
- GECBrush, Scrub, Operating-Room
- CATCannula, Nasal, Oxygen
- FYFCap, Surgical
- JOLCatheter And Tip, Suction
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- FXPCover, Shoe, Operating-Room
- PUIDrape, Surgical, Exempt
- EYQGarment, Protective, For Incontinence
- NABGauze / Sponge,Nonresorbable For External Use
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FMEGown, Examination
- FYAGown, Surgical
- OVRKit, First Aid, Talking
- KDDKit, Surgical Instrument, Disposable
- KHAMask, Scavenging
- OEANon-Surgical Gown
- IMAPack, Heat, Moist
- EZQPouch, Colostomy
- MSHRespirator, Surgical
- HIBSpeculum, Vaginal, Nonmetal
- FXOSuit, Surgical
- KGXTape And Bandage, Adhesive
- FSMTray, Surgical, Instrument
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain