# Nipro Corporation (foreign exporter, Settsu Osaka, JP): 4 new FDA device listings, incl. syringe, balloon inflation, exempt

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Nipro Corporation |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Settsu Osaka, JP |
| New listings | 4 |
| Devices | Syringe, Balloon Inflation, Exempt; Hemodialyzer With Expanded Solute Removal Profile; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Catheter, Percutaneous, Cutting/Scoring |
| Product codes | PTM, QAX, KDI, PNO |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Gastroenterology, Urology |
| Brand names | GM-30 Inflation Device; ELISIO-HX; ELISIO™-H; Aperta NSE PTA Balloon Dilatation Catheter |
| First new listing | 2026-07-24 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 3000247873 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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: 2026-10-28T20:51:27.468Z.
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.