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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

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, SterileKXG1Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apron, ProtectiveIWO1Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Manufactureraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufactureraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufacturer, Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Manufactureraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufactureraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Manufactureraccessdata.fda.gov
Gown, ExaminationFME1Manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Contract manufacturer, Manufactureraccessdata.fda.gov
Kit, First Aid, TalkingOVR1Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pack, Heat, MoistIMA1Manufactureraccessdata.fda.gov
Pouch, ColostomyEZQ1Manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Manufactureraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Manufactureraccessdata.fda.gov
Suit, SurgicalFXO1Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 7, 2026K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYASubstantially EquivalentYadu Medical (Henan) Co., Ltd.accessdata.fda.gov
February 4, 2026K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)FYASubstantially EquivalentYadu Medical (Henan) Co., Ltd.accessdata.fda.gov
December 3, 2025K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYASubstantially EquivalentYadu Medical (Henan) Co., Ltd.accessdata.fda.gov

Compare with other makers

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.