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.
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- 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
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 18, 2026 | K254256 | LUOFUCON® Wound Matrix | QSZ | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 11, 2026 | K252028 | LUOFUCON® Antimicrobial Wound Gel | FRO | Substantially Equivalent | Huizhou Foryou Medical Co., Ltd. | accessdata.fda.gov |
| November 19, 2025 | K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| December 16, 2024 | K240809 | LUOFUCON® Silver Collagen Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| November 13, 2024 | K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 7, 2024 | K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 25, 2024 | K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 27, 2024 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| January 4, 2024 | K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| December 21, 2023 | K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 20, 2022 | K213598 | LUOFUCON Collagen Wound Dressing | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 22, 2022 | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 23, 2022 | K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| January 28, 2021 | K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 1, 2018 | K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| January 24, 2018 | K173196 | SUNTOUCH Dental Dressing | OLR | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| August 17, 2016 | K160022 | LUOFUCON Silicone Ag foam dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 23, 2015 | K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 30, 2013 | K132796 | SUNTOUCH EYE SPEAR | HOZ | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| February 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 23, 2012 | K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING | QSY | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wound Dressing With Animal-Derived Material(S)
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- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrophilic
- All makers of Absorbable Synthetic Wound Dressing
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.