# Kaz USA, Inc., A Helen of Troy Company (specification developer, Marlborough, MA): 4 new FDA device listings, incl. oximeter, infrared, sporting, aviation

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Kaz USA, Inc., A Helen of Troy Company |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Marlborough, MA, US |
| New listings | 4 |
| Devices | Oximeter, Infrared, Sporting, Aviation; System, Measurement, Blood-Pressure, Non-Invasive; Clinical Electronic Thermometer |
| Product codes | OCH, DXN, SDV |
| Device classes | Class II |
| Medical specialties | Cardiovascular, General Hospital |
| Brand names | Braun Pulse Oximeter BPX801US; BUA6120US; BUA6150US; Braun ThermoScan Infrared Ear Thermometer IRT6525; Braun ThermoScan Infrared Ear Thermometer IRT6525AP; Braun ThermoScan Infrared Ear Thermometer IRT6030AP; BUA6450US |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-06-23 |
| FDA registration number | 3006169981 |
| 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: 2026-11-04T21:52:36.524Z.
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.