# Leltek Inc. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Leltek Inc. |
| Owner / operator | Leltek |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | New Taipei City, TW |
| New listings | 3 |
| Devices | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic |
| Product codes | ITX, IYO, IYN |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | Healium Intelliscan LX192LC |
| First new listing | 2026-09-03 |
| Latest new listing | 2026-09-03 |
| FDA registration number | 3014555455 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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.