FDA Registration
Active
🇨🇳 China
WINNER MEDICAL CO., LTD.
Reg #: 3030067857
·
FEI: 3030067857
·
Expires 2026
Products
25
Proprietary Names
98
Establishment Types
2
Classifications
25
Registration Details
- Registration Name
- WINNER MEDICAL CO., LTD.
- Registration Number
- 3030067857
- FEI Number
- 3030067857
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street, Longhua District
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202982
Owner / Operator
- Firm Name
- WINNER MEDICAL CO., LTD.
- Operator Number
- 9012349
- Address
- 42nd Floor, Building No.2, Huilong Business Center, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
- Correspondent
- Xiaomeng Yang
US Agent
- Business Name
- REGISTRAR CORP
- Contact Name
- DAVID LENNARZ
- Address
- 144 Research Drive, Hampton, VA US 23666 , UNITED STATES
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2000-01-24 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-09-30 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2019-02-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2000-01-24 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2008-05-20 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2023-12-20 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2013-01-26 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-12-14 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2019-05-24 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2015-07-08 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2000-01-24 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2017-07-20 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2002-05-07 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-09-01 |
| Parenteral Administration Kit | POR | Class 2 | General Hospital | No | 2025-09-09 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2002-05-07 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2010-05-07 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2003-12-30 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2026-01-13 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-08-06 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2002-05-07 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2024-03-04 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2020-08-06 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2020-06-10 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2000-01-24 |
Proprietary Names
Hydrogel Wound Gel
Surgical tape, Cohesive bandage, Elastic adhesive bandage
Soft Silicone Tape,Silicone Band Aid
ATHLETIC TAPE
Medical Silicone Tape
Silicone Adhesive Tape
ADHESIVE TAPE AND BANDAGE
Silicone tape
non-surgical isolation gown
Surgeon Gown
Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-Woven Sponge Dressing
Sterilux AMD Sterile Bulky Antimicrobial Gauze
Antimicrobial Super Sponge Dressing, 4.5''X4.1YDS-6P, EO
Antimicrobial Super Sponge Dressing 32/12X5,6X6"-12P,2S,EO
Transparent Dressing
Sacrum Silicone Foam Dressing with Border
Silicone Contact Layer
Transparent Film Dressing
Foam Dressing
Silicone Foam Dressing
Hydrocolloid Dressing
Silicone Foam Dressing with Border
ALMORIS Silicone Foam Dressing
Foam dressing without border
Silicone Foam Dressing without Border
Dimora HEEL FOAM DRESSING Without Borde
HidraWear Foam Dressing
Hydrocolloid (Sterile Wound Dressing with Border)
Waterproof Foam Dressing
Hydrocolloid Roll
Sting Free Skin Barrier Wipe
Skin barrier film spray
Skin barrier film wand
Skin and Wound Cleanser
Silicone Ag Foam Dressing
Ag Foam Dressing Adhesive
Silicone Ag Foam Dressing with Border
Ag Foam Dressing Non-adhesive
PHMB Foam Dressing
PHMB non-adhesive foam dressing
PHMB sacral bordered silicone foam dressing with SAF
PHMB bordered foam dressing
PHMB bordered silicone foam dressing with SAF
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border
Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT
Dispossable Dressing Tray
SURGICALCAPS
alcohol
device disinfectant
Cotton Roll, Cotton Ball
Minor Procedure Drape with Adhesive Aperture
Fenestrated drape
Drape
Absorbent drape
X-RAY DETECTABLE GAUZE SPONGES
LARGE STERILE GAUZE PAD
PC swabs without X-ray thread
Conforming stretch gauze
DRYNET
Super Absorbent Dressing
Alginate Dressing
Nonwoven Adhesive wound dressing (Strip)
CMC Gelling Fiber Dressing
Wound Dressing
ALMORIS Alginate Wound Dressing
Activated Charcoal Super Absorbent Dressing
Silicone Super Absorbent Dressing
transparent dressing
Silicone Absorbent Soft Dressing with border
HidraWear Superabsorbent Dressing
Calcium Alginate Wound Dressing
Extra Silver Gelling Fiber Dressing
PC Towel
Incontinence Underpads
Absorbent towel
Collagen Wound Dressing
Wound Dressing With Animal-Derived Material(S)
Antibacterial Gel Wound Dressing
Hearing Aid
Antimicrobial non-woven sponge dressing (OTC)
Antimicrobial gauze sponge dressing (OTC)
Antimicrobial super sponge dressing (OTC)
Medical Mask
Procedure Mask
Surgical Face Mask
Earloops Face Mask
Face Mask
Medical Face Mask
Medical Face Mask Earloop
Silicone Scar Repair Sheet
Silicone Scar Gel
Silicone Scar Gel Ultra
Tape remover pad
Adhesive Romover Wipes
Procedure mask/Surgical mask/Face mask
Medical Earloop Face Mask
Cellasorb Ag+ Gelling Fiber Dressing with Antibacterial Silver
JOBST Comprifore
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility