Suzhou Haowei Medical Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 1 device type, 2 clearances.
Suzhou Haowei Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Device, Vascular, For Promoting Embolization. Its earliest product listing with the FDA dates from 2024.
1device type
2510(k) clearances
Registration
| Registered name | SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033841272 |
| FEI number | 3033841272 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 苏州浩微生物医疗科技有限公司 |
|---|---|
| Unified social credit code | 91320506MA25DR8U62 |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Room 304, Building 4, Tianyun Square No.111, Wusongjiang Avenue, Guoxiang Street Wuzhong District, Suzhou |
| Postal code | 215124 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | Class 2 | UniPearls® Embolic Microspheres | 2024 | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252812 | 2026-07-31 | KRD | Traditional | This company |
| K231554 | 2023-11-14 | KRD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | UniPearls embolization microspheres, Hiswan microcatheter, HiFlamingo occlusion balloon catheter system |
|---|
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.