# W&H Impex Inc. (foreign exporter, Windsor Ontario, CA): 8 new FDA device listings, incl. sterilizer, steam

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | W&H Impex Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Windsor Ontario, CA |
| New listings | 8 |
| Devices | Sterilizer, Steam; Handpiece, Direct Drive, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Catheter, Irrigation; Controller, Foot, Handpiece And Cord; Scaler, Ultrasonic; Drill, Bone, Powered |
| Product codes | FLE, EKX, GFF, GBX, EBW, ELC, DZI |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Dental, General, Plastic Surgery |
| Brand names | Handpiece |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 3007279848 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

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.