Registered establishment in Huaian, Jiangsu, China. 6 device types.
Huaian Youwen Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Sleeve, Limb, Compressible, Pack, Hot Or Cold, Reusable and 4 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
FDA registration record for Huaian Youwen Medical Technology Co., Ltd. | Registered name | HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014542717 |
| FEI number | 3014542717 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Huaian Youwen Medical Technology Co., Ltd. | Chinese legal name | 淮安友文医疗科技有限公司 |
| Source | Baidu Baike |
Location
Address of Huaian Youwen Medical Technology Co., Ltd. | City | Huaian |
| Province | Jiangsu |
| Address | MINBING ROAD, EAST SHUANGGOU TOWN, HONGZE DISTRICT |
| Postal code | 223121 |
| Country | China |
Clearances
No clearance names Huaian Youwen Medical Technology 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.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Huaian Youwen Medical Technology Co., Ltd. | Founded | 2004 |
| Factory area | 10000 m² |
| Main products | DVT compression sleeves, Pneumatic compression garments, Cold therapy wraps, Cold compression therapy systems, Anti-bedsore mattress |
| Certifications | ISO13485, FDA, CE, RoHS, TUV, FCC, EAC |
| Export markets | 60+ countries including Europe, America, Africa, Middle East, Southeast Asia |
| OEM and ODM | Offered |
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.