HuiZhou Foryou Medical Devices Co., Ltd.
HuiZhou Guangdong, CN
HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD. appears in FDA device records in HuiZhou Guangdong, CN. FDA records list 22 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for HuiZhou Foryou Medical Devices Co., Ltd. between 2012 and 2025. The busiest year on record is 2024, with 6. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 6 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | FRO | Substantially Equivalent | |
| K240809 | LUOFUCON® Silver Collagen Dressing | FRO | Substantially Equivalent | |
| 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 | |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | FRO | Substantially Equivalent | |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | KGN | Substantially Equivalent | |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | FRO | Substantially Equivalent | |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | FRO | Substantially Equivalent | |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | FRO | Substantially Equivalent | |
| K213598 | LUOFUCON Collagen Wound Dressing | KGN | Substantially Equivalent | |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | FRO | Substantially Equivalent | |
| K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing | FRO | Substantially Equivalent | |
| K201852 | Surgical Mask-Model Number: Ear Loop, Flat-Pleated | FXX | Substantially Equivalent | |
| K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) | FRO | Substantially Equivalent | |
| K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing | FRO | Substantially Equivalent | |
| K173196 | SUNTOUCH Dental Dressing | OLR | Substantially Equivalent | |
| K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | |
| K160022 | LUOFUCON Silicone Ag foam dressing | FRO | Substantially Equivalent | |
| K141619 | LUOFUCON SILVER FOAM DRESSING | FRO | Substantially Equivalent | |
| K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | FRO | Substantially Equivalent | |
| K132796 | SUNTOUCH EYE SPEAR | HOZ | Substantially Equivalent | |
| K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | |
| K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING | QSY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007735241 | 3007735241 | HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD. | North Shangxia Rd. Dongjiang Hi-tech Industry Park, HuiZhou Guangdong 516005 CN | 2026 | and 8 more, listed in full below |
| 3039592366 | 3039592366 | HuiZhou Foryou Medical Devices Co., LTD. | No.1 Xintang Rd., Ma'an Town, Huicheng District, Huizhou Guangdong 516057 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QSZAbsorbable Synthetic Wound Dressing
- EMXBalloon, Epistaxis
- KMFBandage, Liquid
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal
- MGOClosure, Wound, Adhesive
- CBHDevice, Fixation, Tracheal Tube
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- KCNEar Wick
- MDAElastomer, Silicone, For Scar Management
- NABGauze / Sponge,Nonresorbable For External Use
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- FXXMask, Surgical
- OLROral Wound Dressing
- HOZSponge, Ophthalmic
- KGXTape And Bandage, Adhesive
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain