Nanoentek Inc (specification developer, Seoul, KR): 3 new FDA device listings, incl. counter, differential cell
Nanoentek Inc (Seoul): 3 new FDA device listings, incl. counter, differential cell. Its amount of 3 is above the median of 1 (77th percentile). Dated 100 days ago, it serves as a historical benchmark. Score 75/100. 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: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Nanoentek Inc |
| Owner / operator | NanoEntek, Inc |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Seoul, KR |
| New listings | 3 |
| Devices | Counter, Differential Cell; Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Total Triiodothyronine |
| Product codes | GKZ, JJY, CDP |
| Device classes | Class I, Class II |
| Medical specialties | Hematology, Clinical Chemistry |
| Brand names | ADAMII CD34 System; FREND ImmunoAssay Multi; FREND Free T3 |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-07-27 |
| FDA registration number | 3009092698 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
| Peer records CSV (117 KR 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: 2026-10-28
- 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: Nanoentek Inc and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Nanoentek Inc's amount: 77th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Nanoentek Inc in Seoul?
Nanoentek Inc (Seoul, KR), a specification developer (outsources manufacturing), added 3 FDA device listings between 2026-06-29 and 2026-07-27.
How does Nanoentek 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 100 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Nanoentek Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Nanoentek Inc | Seoul, KR | 3 | 77th | 2026-07-27 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) 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.