Nipro Corporation (foreign exporter, Settsu Osaka, JP): 4 new FDA device listings, incl. syringe, balloon inflation, exempt
Nipro Corporation (Settsu Osaka): 4 new FDA device listings, incl. syringe, balloon inflation, exempt. Its amount of 4 is above the median of 1 (83rd percentile). Dated 77 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 60 related JP DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (61 JP records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-19
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Nipro Corporation and 61 JP peers
- JP DeviceEstablishmentPulse records like this one: 61
- Nipro Corporation's amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Nipro Corporation in Settsu Osaka?
Nipro Corporation (Settsu Osaka, JP), a foreign exporter, added 4 FDA device listings between 2026-07-24 and 2026-08-19.
How does Nipro Corporation compare to other DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 77 days old; check the official source for later updates before acting.
Nipro Corporation vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Nipro Corporation | Settsu Osaka, JP | 4 | 83rd | 2026-08-19 |
| Optikal (Southgate) Ltd | Borehamwood, GB | 3 | 77th | 2026-10-13 |
| Loudwater Trade Finance Ltd | LONDON England, GB | 3 | 77th | 2026-10-09 |
| Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi | Cankaya Ankara, TR | 9 | 92nd | 2026-10-17 |
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DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
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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.