DeviceEstablishmentPulse / report
Euroimmun Us Inc. (other, Mountain Lakes, NJ): 3 new FDA device listings, incl. extractable antinuclear antibody, antigen and control
Euroimmun Us Inc. (Mountain Lakes, New Jersey): 3 new FDA device listings, incl. extractable antinuclear antibody, antigen and control. Its amount of 3 is above the median of 1 (77th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 65/100. 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: 48 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Euroimmun Us Inc. |
| Owner / operator | EUROIMMUN US Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Mountain Lakes, NJ, US |
| New listings | 3 |
| Devices | Extractable Antinuclear Antibody, Antigen And Control; Anti-Ss-A 52 Autoantibodies; Anti-Ss-A Ro60 Autoantibodies |
| Product codes | LLL, OBE, PET |
| Device classes | Class II |
| Medical specialties | Immunology |
| Brand names | IDS SS-A/Ro; IDS SS-A/RO 60 kDa; IDS SS-B/La |
| First new listing | 2026-09-10 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 3007118747 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
| Peer records CSV (49 NJ 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: 2026-09-10
- Data refreshed: 2026-10-28
- 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, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Euroimmun Us Inc. and 49 New Jersey peers
- New Jersey DeviceEstablishmentPulse records like this one: 49
- Euroimmun Us Inc.'s amount: 77th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $9,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Euroimmun Us Inc. in Mountain Lakes, New Jersey?
Euroimmun Us Inc. (Mountain Lakes, NJ), a other, added 3 FDA device listings on 2026-09-10.
How does Euroimmun Us Inc. compare to other New Jersey DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 55 days old; check the official source for later updates before acting.
Euroimmun Us Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Euroimmun Us Inc. | Mountain Lakes, NJ | 3 | 77th | 2026-09-10 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Rohrer Aesthetics, Inc. | Homewood, AL | 3 | 77th | 2026-09-09 |
| Integrity United Inc Dba Costcare | Anaheim, CA | 3 | 77th | 2026-09-08 |
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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.