Xianning ECO Medical Articles Co., Ltd.
Registered establishment in Xianning, Hubei, China. 4 device types, 1 clearance.
Xianning ECO Medical Articles Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, Surgical and 2 other device types. Its earliest product listing with the FDA dates from 2010.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | XIANNING ECO MEDICAL ARTICLES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008240985 |
| FEI number | 3008240985 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 湖北省爱科医疗器械有限公司 |
|---|---|
| Source | Chinese medical device directory |
Location
| City | Xianning |
|---|---|
| Province | Hubei |
| Address | No.16,Shutai Street |
| Postal code | 437000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cap, Surgical | Class 1 | Disposable Surgicalbouffant CAP | 2010 | 178 |
| Mask, Scavenging | Class 1 | Scavenging Face Mask, Disposable Mask | 2010 | 158 |
| Mask, Surgical | Class 2 | Medline Surgical Face Mask and Medline Procedural Face Mask, Surgical Face Masks（MEDLINE ADMIN KITS） | 2012 | 125 |
| Non-Surgical Gown | Class 1 | Isolation Gown, Coverall, Examination Gown | 2010 | 318 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210698 | 2021-08-19 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 500 |
|---|---|
| Factory area | 33000 m² |
| Main products | face masks, non-woven medical products, disposable medical products |
| Certifications | ISO13485, CE, FDA |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Kingstar Medical (Xianning) Co., Ltd. | 17 |
| Hubei Dacheng Medical Technology Co., Ltd. | 12 |
| Xianning Full Guard Medical Products Co., Ltd. | 10 |
| Hopefull Medical Equipment Co., Ltd. | 7 |
| Lifestyles Health Products 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.