Privapath Diagnostics Ltd (manufacturer, Dublin 11 Dublin(County), IE): 1 new FDA device listing, incl. device for home collection and transport of vaginal specimens by lay u
Privapath Diagnostics Ltd (Dublin 11 Dublin(County)): 1 new FDA device listing, incl. device for home collection and transport of vaginal specimens by lay u. Its amount of 1 is above the median of 2 (50th percentile). Dated 93 days ago, it serves as a historical benchmark. Score 60/100. 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 15 published fields of this record are shown below. Locked: 20 related IE DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Privapath Diagnostics Ltd |
| Owner / operator | LetsGetChecked Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Dublin 11 Dublin(County), IE |
| New listings | 1 |
| Devices | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay |
| Product codes | SEP |
| Device classes | Class II |
| Medical specialties | Microbiology |
| Brand names | Onclarity Self-Collection Kit |
| First new listing | 2026-08-05 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 3015209536 |
| 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: 2026-08-05
- 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: Privapath Diagnostics Ltd and 21 IE peers
- IE DeviceEstablishmentPulse records like this one: 21
- Privapath Diagnostics Ltd'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)
60 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Privapath Diagnostics Ltd in Dublin 11 Dublin(County)?
Privapath Diagnostics Ltd (Dublin 11 Dublin(County), IE), a manufacturer, added 1 FDA device listing on 2026-08-05.
How does Privapath Diagnostics Ltd 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 93 days old; check the official source for later updates before acting.
Privapath Diagnostics Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Privapath Diagnostics Ltd | Dublin 11 Dublin(County), IE | 1 | 50th | 2026-08-05 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Tornier, Inc. | Bloomington, MN | 3 | 77th | 2026-10-21 |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL | 3 | 77th | 2026-10-20 |
Related records
- Applied Medical Resources Corp.
- Inter-Med, Inc.
- Intuitive Surgical, Inc.
- Biomerieux, Inc.
- Intuitive Surgical, Inc.
- Masimo Corporation
- Centerpoint Systems LLC
- Tornier, Inc.
- Treace Medical Concepts, Inc.
- Coopersurgical, Inc.
- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
- Boston Scientific Corporation
DeviceEstablishmentPulse: 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.