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Data / Medical devices / China / Dongguan Shin Yi Healthcare Products Factory

Dongguan Shin Yi Healthcare Products Factory: FDA-registered device maker in DONG GUAN CITY Guangdong, China, 1 510(k) clearance

Dongguan Shin Yi Healthcare Products Factory is registered with the FDA (registration 9680357) in DONG GUAN CITY Guangdong, China. It lists 30 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
9680357
FEI number
3004829691
Address
No. 17, Banhu Rd, /No.54 Hong Sheng Road, Diao Lang Village Huang Jiang Town, DONG GUAN CITY Guangdong, China, 523750
Owner or operator
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY (9008465)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer
First device listed
February 28, 1995
Registered through
2026
Brand names listed
ABSORBENT TOWEL, Accessories Kit, Bandage, Cast, Bandage, cast, COVERALL, DISPOSABLE BOUFFANT CAPS, DRAIN BAG POUCH, DRAPE SHEET and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Bandage, CastITG1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Contract manufactureraccessdata.fda.gov
Cover, Barrier, ProtectiveMMP2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Cover, CastKIA1Contract manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Contract manufactureraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Contract manufactureraccessdata.fda.gov
Drape, Pure Latex Sheet, With Self-Retaining Finger CotEYX2Contract manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Dressing, CompressionMHW1Contract manufactureraccessdata.fda.gov
Dressing, Wound, DrugFROUContract sterilizeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract sterilizeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract sterilizeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Contract manufactureraccessdata.fda.gov
General Surgery TrayLRO2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Gown, ExaminationFME1Contract manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Mask, SurgicalFXX2Contract manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Manufactureraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Respirator, SurgicalMSH2Manufactureraccessdata.fda.gov
Suit, SurgicalFXO1Contract manufactureraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Contract manufactureraccessdata.fda.gov
Table, Cysto, Non-ElectricalEYH1Contract manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufactureraccessdata.fda.gov
Tray, Surgical, NeedleFSH1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Wrap, SterilizationFRG2Contract manufactureraccessdata.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
April 4, 2018K172963Master-Frank N95 Particulate RespiratorMSHSubstantially EquivalentMaster & Frank Enterprise Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 4, 2018. 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.