Data / Medical devices / China / Suzhou Haowei Medical Technology Co., Ltd.
Suzhou Haowei Medical Technology Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Suzhou Haowei Medical Technology Co., Ltd. is registered with the FDA (registration 3033841272) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033841272
- Address
- Room 304, Building 4, Tianyun Square No.111, Wusongjiang Avenue, Guoxiang Street Wuzhong District, Suzhou, Suzhou Jiangsu, China, 215124
- Owner or operator
- Suzhou Haowei Medical Technology Co., Ltd. (10091629)
- Roles
- Manufacturer
- First device listed
- October 20, 2024
- Registered through
- 2026
- Brand names listed
- UniPearls® Embolic Microspheres
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 14, 2023 | K231554 | UniPearls® Embolic Microspheres | KRD | Substantially Equivalent | Suzhou Haowei Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.