Nanoentek America, Inc (other, North Waltham, MA): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine
Nanoentek America, Inc (North Waltham, Massachusetts): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine. Its amount of 3 is above the median of 2 (77th percentile). Dated 101 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: 3 · 77th percentile of 2,709 DeviceEstablishmentPulse records · 1.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 72 related MA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Nanoentek America, Inc |
| Owner / operator | NanoEntek, Inc |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | North Waltham, MA, US |
| New listings | 3 |
| Devices | Radioimmunoassay, Total Triiodothyronine; Multi-Analyte Controls, All Kinds (Assayed); Counter, Differential Cell |
| Product codes | CDP, JJY, GKZ |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, Hematology |
| Brand names | FREND Free T3; FREND ImmunoAssay Multi; ADAMII CD34 System |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-07-27 |
| FDA registration number | 3007113174 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,709 (median 2, 1.5x median) |
| Peer records CSV (73 MA 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: 2026-07-27
- 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: Nanoentek America, Inc and 73 Massachusetts peers
- Massachusetts DeviceEstablishmentPulse records like this one: 73
- Nanoentek America, Inc's amount: 77th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $14,600 (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 Nanoentek America, Inc in North Waltham, Massachusetts?
Nanoentek America, Inc (North Waltham, MA), a other, added 3 FDA device listings between 2026-06-29 and 2026-07-27.
How does Nanoentek America, Inc compare to other Massachusetts DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. It is 101 days old; check the official source for later updates before acting.
Nanoentek America, Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Nanoentek America, Inc | North Waltham, MA | 3 | 77th | 2026-07-27 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Merz North America, Inc. | Sturtevant, WI | 4 | 83rd | 2026-09-23 |
| Rapid Medical Inc. | Southlake, TX | 4 | 83rd | 2026-09-20 |
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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.