Contract manufacturerSURMODICS, INC. (Eden Prairie, MN)MinnesotaCardiovascularClass II
SURMODICS, INC.
Contract manufacturer · Eden Prairie, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3014687026 (openFDA record; or search FDA's registration database)
- FEI number
- 3014687026
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- SURMODICS, INC. (FDA owner/operator no. 9070604)
- Registered address
- 7905 Golden Triangle Drive Suite 190, Eden Prairie, MN 55344
- Contract listings
- 4 device listings, 2 product codes, first listed Apr 26, 2022
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract manufacturing | Apr 26, 2022 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Class II | Cardiovascular | Contract manufacturing | Apr 26, 2022 |