Lake Region Medical Limited (contract manufacturer, NEW ROSS Wexford, IE): 1 new FDA device listing, incl. introducer, catheter
Lake Region Medical Limited (NEW ROSS Wexford): 1 new FDA device listing, incl. introducer, catheter. Its amount of 1 is above the median of 2 (50th percentile). Dated 45 days ago, it serves as a historical benchmark. Score 65/100. As of 2026-11-04, 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: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 20 related IE DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Lake Region Medical Limited |
| Owner / operator | Lake Region Medical |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | NEW ROSS Wexford, IE |
| New listings | 1 |
| Devices | Introducer, Catheter |
| Product codes | DYB |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| First new listing | 2026-09-21 |
| Latest new listing | 2026-09-21 |
| FDA registration number | 9681477 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (21 IE 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: 2026-09-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Lake Region Medical Limited and 21 IE peers
- IE DeviceEstablishmentPulse records like this one: 21
- Lake Region Medical Limited's amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every IE peer: $4,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Lake Region Medical Limited in NEW ROSS Wexford?
Lake Region Medical Limited (NEW ROSS Wexford, IE), a contract manufacturer, added 1 FDA device listing on 2026-09-21.
How does Lake Region Medical Limited compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 45 days old, still within a typical 45-day follow-up window.
Lake Region Medical Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Lake Region Medical Limited | NEW ROSS Wexford, IE | 1 | 50th | 2026-09-21 |
| 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 |
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DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: Foreign establishment
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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
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.