Huizhou Foryou Medical Devices Co., Ltd.
Manufacturer and brand owner in Huizhou, Guangdong, China. 18 device types, 7 products catalogued, 23 clearances.
Huizhou Foryou Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Ear Wick, Bandage, Liquid and 16 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
18device types registered with the FDA
7products catalogued under its own name
23510(k) clearances
Registration
| Registered name | HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007735241 |
| FEI number | 3007735241 |
| DUNS | 529904325 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 惠州华阳医疗器械有限公司 |
|---|---|
| Unified social credit code | 91441300771878655A |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Huizhou |
|---|---|
| Province | Guangdong |
| Address | North Shangxia Rd. Dongjiang Hi-tech Industry Park |
| Postal code | 516005 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | Class U | LUOFUCON® Wound Matrix | 2026 | 2 |
| Balloon, Epistaxis | Class 1 | Nasal Dressing, SUNTOUCH® Hemostatic Rhinobyon | 2012 | 6 |
| Bandage, Liquid | Class 1 | 2025 | 3 | |
| Burr, Corneal, Battery Powered, Rust Ring Removal | Class 1 | Medical Sponge Tips | 2014 | 4 |
| Closure, Wound, Adhesive | Class 1 | LUOFUCON Composite Dressing | 2021 | 22 |
| Device, Fixation, Tracheal Tube | Class 1 | LUOFUCON Catheter Fixation Device | 2022 | 46 |
| Dressing, Wound, Drug | Class U | LUOFUCON Sliver PU Antibacterial Foam Dressing, LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.), LUOFUCON PHMB Antibacterial Alginate Wound Dressing, LUOFUCON PHMB Alginate Dressing, LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing and 18 more | 2013 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | LUOFUCON Medical Hydrogel Dressing, LUOFUCON Amorphous Hydrogel Dressing | 2009 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | LUOFUCON Alginate Dressing, LUOFUCON Super absorbent dressing, LUOFUCON Silicone Post-Op Dressing, LUOFUCON Gelling Fiber Dressing, LUOFUCON HyperSorb Hydrofiber Wound Pad, LUOFUCON Activated charcoal absorbent dressing | 2009 | 195 |
| Dressing, Wound, Occlusive | Class 1 | LUOFUCON Foam Dressing, LUOFUCON Silicone Foam Dressing, Silicone Wound Contact Dressing, LUOFUCON Silicone Film Dressing | 2009 | 183 |
| Ear Wick | Class 1 | Ear Pack, Ear Wick, Ear Tampon | 2013 | 2 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Gel Scar Dressing, Silicone Gel Sheet | 2012 | 85 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Soluble Hemostatic Gauze | 2011 | 266 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Class U | Topical Hemostatic Dressing | 2012 | 10 |
| Oral Wound Dressing | Class U | SUNTOUCH Dental Dressing | 2018 | 2 |
| Sponge, Ophthalmic | Class 2 | Suntouch Eye Spear | 2013 | 7 |
| Tape And Bandage, Adhesive | Class 1 | LUOFUCON Silicone Tape | 2018 | 353 |
| Wound Dressing With Animal-Derived Material(S) | Class U | LUOFUCON® Silver Collagen Dressing, LUOFUCON® Collagen Particles (Collagen Wound Dressing), LUOFUCON Collagen Wound Dressing | 2022 | 12 |
Own-Brand Listings
Clearances
23 clearances name Huizhou Foryou Medical Devices Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254256 | 2026-08-18 | QSZ | Traditional | This company |
| K250642 | 2025-11-19 | FRO | Traditional | This company |
| K240809 | 2024-12-16 | FRO | Traditional | This company |
| K242856 | 2024-11-13 | FRO | Special | This company |
| K240485 | 2024-10-07 | FRO | Traditional | This company |
| K232796 | 2024-04-25 | KGN | Traditional | This company |
| K223360 | 2024-03-27 | FRO | Traditional | This company |
| K221110 | 2024-01-04 | FRO | Traditional | This company |
| K223359 | 2023-12-21 | FRO | Traditional | This company |
| K213598 | 2022-09-20 | KGN | Traditional | This company |
| K211123 | 2022-04-22 | FRO | Traditional | This company |
| K210718 | 2022-03-23 | FRO | Traditional | This company |
| K201852 | 2021-03-02 | FXX | Abbreviated | This company |
| K201016 | 2021-01-28 | FRO | Traditional | This company |
| K172554 | 2018-05-01 | FRO | Traditional | This company |
| K173196 | 2018-01-24 | OLR | Traditional | This company |
| K170077 | 2017-03-30 | FRO | Traditional | This company |
| K160022 | 2016-08-17 | FRO | Traditional | This company |
| K141619 | 2015-04-06 | FRO | Traditional | This company |
| K140954 | 2015-03-23 | FRO | Traditional | This company |
| K132796 | 2013-10-30 | HOZ | Traditional | This company |
| K120181 | 2013-02-14 | FRO | Traditional | This company |
| K112800 | 2012-05-23 | QSY | Traditional | This company |
| K252028 | 2026-03-11 | FRO | Traditional | Huizhou Foryou Medical Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 301-500 |
| Main products | Wound care dressings (LUOFUCON), Hemostatic products (SUNTOUCH), Bioabsorbable materials (FORUSORB) |
| Certifications | ISO13485, ISO 9001, CE, FDA |
| Export markets | Global |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.