# Acist Medical Systems, Inc. (manufacturer, Eden Prairie, MN): 3 new FDA device listings, incl. injector and syringe, angiographic

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Acist Medical Systems, Inc. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Eden Prairie, MN, US |
| New listings | 3 |
| Devices | Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic |
| Product codes | DXT, IZQ |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | VeraPro S100 LV1; VeraPro AngioTouch HiFi 165; VeraPro S100; VeraPro AngioTouch FLX 165; VeraPro AMT; Processing Unit Bed Mount; ACIST Pro Cart; Triple Transducer Cable |
| First new listing | 2026-05-14 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 2134243 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.
