Leltek Inc. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic
Leltek Inc. (New Taipei City): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic. Its amount of 3 is above the median of 1 (77th percentile). Dated 63 days ago, it serves as a historical benchmark. Score 70/100. 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: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 49 related TW DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
| Peer records CSV (50 TW 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: 2026-09-03
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (TW first): Zimmer Biomet Taiwan Co., Ltd. (foreign exporter, Taipei, TW · Syntec Scientific Corp. (contract manufacturer, CHANG HUA Ch · Astron Medtech Co., Ltd. (repackager or relabeler, Taipei, T · Miing Wei Co., Ltd. (contract manufacturer, Tsao-Twon Nantou · United Orthopedic Corp. (manufacturer, Kaohsiung, TW) · Browse all by state and category →
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: Leltek Inc. and 50 TW peers
- TW DeviceEstablishmentPulse records like this one: 50
- Leltek Inc.'s amount: 77th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every TW peer: $10,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Leltek Inc. in New Taipei City?
Leltek Inc. (New Taipei City, TW), a contract manufacturer, added 3 FDA device listings on 2026-09-03.
How does Leltek Inc. compare to other DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 63 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Leltek Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Leltek Inc. | New Taipei City, TW | 3 | 77th | 2026-09-03 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
Related records
DeviceEstablishmentPulse: Contract manufacturer 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.