Winner Medical (Huanggang) Co., Ltd.
Registered establishment in Huanggang, Hubei, China. 9 device types.
Winner Medical (Huanggang) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Bandage, Elastic and 7 other device types. Its earliest product listing with the FDA dates from 2000.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007966889 |
| FEI number | 3007966889 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 稳健医疗（黄冈）有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Huanggang |
|---|---|
| Province | Hubei |
| Address | Winner Industrial Park, Te1,Chibi Road |
| Postal code | 438000 |
| Country | China |
Group
Winner Medical (Huanggang) Co., Ltd. is one of 8 plants registered under WINNER MEDICAL CO., LTD..
| Plant | City | Device types |
|---|---|---|
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | 13 |
| Winner Medical (Wuhan) Co., Ltd. | Wuhan | 9 |
| Winner Medical Co., Ltd. | Shenzhen | 25 |
| Nature Health Development(Hong Kong)Co., Limited | Hong Kong | 2 |
| Winner Medical (Jiayu) Co., Ltd. | Jiayu | 7 |
| Winner Medical Co., Ltd., Shenzhen Branch | Shenzhen | 2 |
| Nature Health Trading (Hong Kong) Co., Limited | Hongkong | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | JOBST Comprifore | 2000 | 280 |
| Dressing, Wound, Drug | Class U | PHMB Foam Dressing, PHMB bordered foam dressing, PHMB non-adhesive foam dressing, PHMB bordered silicone foam dressing with SAF, PHMB sacral bordered silicone foam dressing with SAF, Silicone Ag Foam Dressing and 4 more | 2020 | 48 |
| Dressing, Wound, Hydrophilic | Class 1 | Super Absorbent Dressing, Alginate Dressing, Nonwoven Adhesive wound dressing (Strip), Activated Charcoal Super Absorbent Dressing, Silicone Absorbent Soft Dressing with border, HidraWear Superabsorbent Dressing and 6 more | 2013 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Transparent Dressing, Silicone Contact Layer, Transparent Film Dressing, Foam Dressing, Hydrocolloid Dressing, Hydrocolloid (Sterile Wound Dressing with Border) and 9 more | 2013 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Repair Sheet, Silicone Scar Gel, Silicone Scar Gel Ultra | 2020 | 85 |
| Fiber, Medical, Absorbent | Class 1 | PC Towel, Incontinence Underpads, Absorbent towel | 2002 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | PC swabs without X-ray thread, Conforming stretch gauze, Large Sterile Gauze PAD, Drynet | 2010 | 266 |
| Mask, Surgical | Class 2 | Procedure mask/Surgical mask/Face mask, Medical Earloop Face Mask, Surgical Face Mask, Medical Mask, Earloops Face Mask, Face Mask and 3 more | 2007 | 125 |
| Tape And Bandage, Adhesive | Class 1 | Surgical tape, Cohesive bandage, Elastic adhesive bandage, Soft Silicone Tape,Silicone Band Aid, Athletic Tape, Adhesive Tape AND Bandage, Medical Silicone Tape, Silicone tape and 1 more | 2000 | 353 |
Clearances
No clearance names Winner Medical (Huanggang) Co., Ltd. as applicant. One 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 |
|---|---|---|---|---|
| K895077 | 1989-11-03 | FXX | Traditional | Ashton Medical Products, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1991 |
|---|---|
| Employees | 12000 |
| Factory area | 550,000 m2 |
| Main products | Surgical gowns, Foam dressings with silicone, Gelling fiber dressings, Alcohol prep pads, Bandages |
| Certifications | CE, ISO13485 |
| Export markets | 110+ countries |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Gauke (Hubei) Healthcare Co., Ltd. | 36 |
| Hubei Junyan Medical Science & Technology Co., Ltd. | 5 |
| Hubei Rightway Technology Co., Ltd. | 2 |
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.