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Data / Medical devices / China / Huizhou Foryou Medical Devices Co.,ltd.

Huizhou Foryou Medical Devices Co.,ltd.: FDA-registered device maker in HuiZhou Guangdong, China, 22 510(k) clearances

Huizhou Foryou Medical Devices Co.,ltd. is registered with the FDA (registration 3007735241) in HuiZhou Guangdong, China. It lists 18 device types. The FDA files 22 510(k) clearances under its listings, the newest dated August 18, 2026. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3007735241
Address
North Shangxia Rd. Dongjiang Hi-tech Industry Park, HuiZhou Guangdong, China, 516005
Owner or operator
HUIZHOU FORYOU MEDICAL DEVICES CO LTD (10029091)
Roles
Contract manufacturer, Manufacturer
First device listed
April 3, 2009
Registered through
2027
Brand names listed
Ear Pack, Ear Tampon, Ear Wick, LOUFUCON Ag+ Antibacterial Foam Dressing, LOUFUCON Ag+ Foam Dressing, LUOFUCON Activated charcoal absorbent dressing, LUOFUCON Alginate Dressing, LUOFUCON Amorphous Hydrogel Dressing and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorbable Synthetic Wound DressingQSZUManufactureraccessdata.fda.gov
Balloon, EpistaxisEMX1Contract manufacturer, Manufactureraccessdata.fda.gov
Bandage, LiquidKMF1Contract manufactureraccessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Contract manufactureraccessdata.fda.gov
Closure, Wound, AdhesiveMGO1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Contract manufacturer, Manufactureraccessdata.fda.gov
Dressing, Wound, DrugFROUContract manufacturer, Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract manufacturer, Manufactureraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Contract manufacturer, Manufactureraccessdata.fda.gov
Ear WickKCN1Contract manufacturer, Manufactureraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Contract manufacturer, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract manufacturer, Manufactureraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUManufactureraccessdata.fda.gov
Oral Wound DressingOLRUManufactureraccessdata.fda.gov
Sponge, OphthalmicHOZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufacturer, Manufactureraccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNUManufactureraccessdata.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 18, 2026K254256LUOFUCON® Wound MatrixQSZSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 11, 2026K252028LUOFUCON® Antimicrobial Wound GelFROSubstantially EquivalentHuizhou Foryou Medical Co., Ltd.accessdata.fda.gov
November 19, 2025K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)FROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
December 16, 2024K240809LUOFUCON® Silver Collagen DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
November 13, 2024K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)FROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
October 7, 2024K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)FROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
April 25, 2024K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)KGNSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 27, 2024K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
January 4, 2024K221110LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
December 21, 2023K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
September 20, 2022K213598LUOFUCON Collagen Wound DressingKGNSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
April 22, 2022K211123LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 23, 2022K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
January 28, 2021K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)FROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
May 1, 2018K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
January 24, 2018K173196SUNTOUCH Dental DressingOLRSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 30, 2017K170077LUOFUCON Silicone Ag Foam Dressing with BorderFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
August 17, 2016K160022LUOFUCON Silicone Ag foam dressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 23, 2015K140954LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSINGFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
October 30, 2013K132796SUNTOUCH EYE SPEARHOZSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
February 14, 2013K120181LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
May 23, 2012K112800SUNTOUCH TOPICAL HEMOSTATIC DRESSINGQSYSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 18, 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.