Danyang Huayi Medical Supply & Equipment Co., Ltd.
Registered establishment in Danyang, Jiangsu, China. 11 device types, 3 clearances.
Danyang Huayi Medical Supply & Equipment Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Chair, Geriatric, Table, Mechanical and 9 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006534178 |
| FEI number | 3006534178 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 丹阳市华一医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Danyang |
|---|---|
| Province | Jiangsu |
| Address | NO.1 ZHENXING RD, YUNYANG |
| Postal code | 212300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Attachment, Commode, Wheelchair | Class 1 | Commode Chair | 2017 | 70 |
| Chair, Adjustable, Mechanical | Class 1 | 2007 | 46 | |
| Chair, Geriatric | Class 1 | 2019 | 11 | |
| Components, Wheelchair | Class 1 | 2008 | 54 | |
| Footrest, Wheelchair | Class 1 | 2007 | 25 | |
| Generator, Oxygen, Portable | Class 2 | 2021 | 22 | |
| Portable Liquid Oxygen Unit Stand | Class 1 | Portable Liquid Oxygen Unit Stand | 2017 | 11 |
| Regulator, Pressure, Gas Cylinder | Class 1 | 2008 | 27 | |
| Table, Mechanical | Class 1 | Overbed table | 2014 | 46 |
| Walker, Mechanical | Class 1 | Knee walker | 2010 | 183 |
| Wheelchair, Mechanical | Class 1 | 2008 | 46 |
Clearances
3 clearances name Danyang Huayi Medical Supply & Equipment Co., Ltd. as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K091482 | 2009-07-06 | IOR | Traditional | This company |
| K080207 | 2008-03-12 | IOR | Traditional | This company |
| K080114 | 2008-02-15 | IOR | Traditional | This company |
| K083559 | 2009-09-04 | CAW | Traditional | Jiangsu Yuyue Medical Equipment & Supply Company Limited |
| K002671 | 2000-10-11 | IOR | Traditional | Jiangsu Intco Medical Equipment & Supply Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Wheelchairs, Medical equipment, Rehabilitation care products |
|---|---|
| Certifications | CE |
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.