# Nihon Kohden America, Inc. (manufacturer, Irvine, CA): 5 new FDA device listings, incl. tape and bandage, adhesive

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Nihon Kohden America, Inc. |
| Owner / operator | Nihon Kohden Corp. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Irvine, CA, US |
| New listings | 5 |
| Devices | Tape And Bandage, Adhesive; Standard Polysomnograph With Electroencephalograph; Stimulator, Photic, Evoked Response; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software |
| Product codes | KGX, OLV, GWE, GWQ, OLT |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Neurology |
| Brand names | YS-111P7 (P263A); BLUPRO Attachment Tape; BLUPRO Attachment Tape, YS-111P7; JE-940A; Neurofax NE; LS-940A, Photic Stimulator; LS-940A-ARM; LS-940A-OLY |
| First new listing | 2026-06-05 |
| Latest new listing | 2026-08-06 |
| FDA registration number | 2080783 |
| Registration expires | 2026-12-31 |

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