Data / Medical devices / China / Suzhou Hengrui Hongyuan Medical Co., Ltd.
Suzhou Hengrui Hongyuan Medical Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 2 510(k) clearances
Suzhou Hengrui Hongyuan Medical Co., Ltd. is registered with the FDA (registration 3031240343) in Suzhou Jiangsu, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031240343
- Address
- No. 100, Tangjiabang Road, Suzhou Industrial Park, Suzhou Jiangsu, China, 215123
- Owner or operator
- Suzhou Hengrui Hongyuan Medical Co., Ltd. (10090677)
- Roles
- Manufacturer
- First device listed
- April 28, 2024
- Registered through
- 2026
- Brand names listed
- HRSpheres Narrow-Size Embolic Microspheres, RAPIDTHRU DA Micro Catheter and Guidewire System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| April 11, 2022 | K212719 | Micro Catheter and Guidewire System | KRA | Substantially Equivalent | Suzhou Hengrui Hongyuan Medical Co., Ltd. | accessdata.fda.gov |
| October 1, 2021 | K210562 | HRSpheres Narrow-Size Embolic Microspheres | KRD | Substantially Equivalent | Suzhou Hengrui Hongyuan Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Continuous Flush
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Agents, Embolic, For Treatment Of Uterine Fibroids
Updated April 11, 2022. 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.