Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007735241

FEI Number

3007735241

Entity Name

HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD.

City/State/Country

HuiZhou Guangdong, CN

Establishment Address

North Shangxia Rd. Dongjiang Hi-tech Industry Park, HuiZhou Guangdong 516005, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HUIZHOU FORYOU MEDICAL DEVICES CO LTD (Owner Number: 10029091)

Owner / Operator Contact Address

North Shangxia Rd. Dongjiang Hi-tech Industry Park,, HuiZhou, CN-GD 516005, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Topical Hemostatic Dressing LUOFUCON Alginate Dressing LUOFUCON Super absorbent dressing LUOFUCON Silicone Post-Op Dressing LUOFUCON Gelling Fiber Dressing LUOFUCON HyperSorb Hydrofiber Wound Pad LOUFUCON Activated charcoal absorbent dressing LUOFUCON® Silver Collagen Dressing LUOFUCON® Antibacterial Gelling Fiber Cover Dressing (OTC use) LUOFUCON® Silver Gelling Fiber Surgical Dressing (Prescription use) LOUFUCON Ag+ Antibacterial Foam Dressing LOUFUCON Ag+ Foam Dressing LUOFUCON® Wound Gel Extra LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use) LUOFUCON Amorphous Hydrogel Dressing LUOFUCON Medical Hydrogel Dressing LUOFUCON Silver Wound Gel LUOFUCON Silver Antimicrobial Wound Gel Ear Tampon Ear Wick Ear Pack LUOFUCON Catheter Fixation Device Soluble Hemostatic Gauze LUOFUCON Silicone Tape Medical Sponge Tips LUOFUCON Sliver PU Antibacterial Foam Dressing Luofucon Antibacterial Alginate Dressing Luofucon Silver Alginate Dressing LUOFUCON PHMB Alginate Dressing LUOFUCON PHMB Antibacterial Alginate Wound Dressing Suntouch Eye Spear Nasal Dressing SUNTOUCH® Hemostatic Rhinobyon LUOFUCON Collagen Wound Dressing SUNTOUCH Dental Dressing LUOFUCON Silver Antibacterial Gelling Fiber Dressing LUOFUCON Extra Silver Gelling Fiber Dressing LUOFUCON® Collagen Particles (Collagen Wound Dressing)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2012-06-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-12-23
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-01-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-01-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-04-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-11-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-04-07
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2009-04-03
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2025-06-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-04-25
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2013-02-05
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2022-08-19
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-08-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-10-22
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2014-03-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-03-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-03-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-01-29
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2013-11-12
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2012-03-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-09-27
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2018-01-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-03-24
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-04-29
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2025-06-16

Official Correspondent

Jin Tuan Lin

US Agent Details

Stanley H. Salot, Jr. Business: Business & Quality Process Management, LLC (BQPM, LLC) Email: Stan.Salot@Bqpm.com Phone: (510) 7734165

Related Public Records

Same Entity

HUIZHOU FORYOU MEDICAL DEVICES CO LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3039592366	HuiZhou Foryou Medical Devices Co., LTD.	Huizhou Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007735241. Last updated year: 2026. Please use registration number 3007735241 when referencing this establishment in official correspondence.