Contract manufacturerACIST MEDICAL SYSTEMS, INC. (Eden Prairie, MN)MinnesotaCardiovascularRadiologyClass II
ACIST MEDICAL SYSTEMS, INC.
Contract manufacturer ยท Eden Prairie, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2134243 (openFDA record; or search FDA's registration database)
- FEI number
- 3001726808
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- ACIST MEDICAL SYSTEMS, INC. (FDA owner/operator no. 9028115)
- Registered address
- 7905 FULLER ROAD, Eden Prairie, MN 55344
- Contract listings
- 4 device listings, 3 product codes, first listed Jul 10, 2008
- 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 |
|---|---|---|---|---|---|
| DSB | Plethysmograph, Impedance | Class II | Cardiovascular | Contract manufacturing | Jul 10, 2008 |
| IZQ | Injector, Contrast Medium, Automatic | Class II | Cardiovascular | Contract manufacturing | Jul 10, 2008 |
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | Contract manufacturing | Jul 10, 2008 |