Topwide (Hubei) Medical Products Manufacturer
Registered establishment in Xiantao, Hubei, China. 4 device types, 1 clearance.
Topwide (Hubei) Medical Products Manufacturer is a contract manufacturer holding a current FDA establishment registration. The registration covers Non-Surgical Gown, Accessory, Surgical Apparel and 2 other device types. Its earliest product listing with the FDA dates from 2014.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | TOPWIDE (HUBEI) MEDICAL PRODUCTS MANUFACTURER |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011308135 |
| FEI number | 3011308135 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 湖北宏宇医用制品有限公司 |
|---|---|
| Unified social credit code | 91429004739107404M |
| Source | NMPA UDI database |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | 19 Xianhong Road, Xin Li Ren Kou |
| Postal code | 433012 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Topwide (Hubei) Medical Products Manufacturer | 2014 | 439 |
| Bedding, Disposable, Medical | Class 1 | Medline Industries, LP | 2025 | 308 |
| Cover, Shoe, Operating-Room | Class 1 | Topwide (Hubei) Medical Products Manufacturer | 2020 | 176 |
| Non-Surgical Gown | Class 1 | Topwide (Hubei) Medical Products Manufacturer | 2017 | 318 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210102 | 2021-12-17 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 280 |
| Factory area | 28,380 m² |
| Main products | Disposable protective equipment, Medical dressings |
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.