EmCyte Corporation (specification developer, Fort Myers, FL): 2 new FDA device listings, incl. powered microneedle device
EmCyte Corporation (Fort Myers, Florida): 2 new FDA device listings, incl. powered microneedle device. Its amount of 2 is above the median of 1 (69th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 80/100. 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: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 83 related FL DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | EmCyte Corporation |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Fort Myers, FL, US |
| New listings | 2 |
| Devices | Powered Microneedle Device; Research Use Only/Hematology Devices |
| Product codes | QAI, OTQ |
| Device classes | Class II, Not classified |
| Medical specialties | General, Plastic Surgery |
| Brand names | EMSTYLE SKIN VITALIZE; RegeniSTAT AI Platelet Analyzer |
| First new listing | 2026-07-15 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 1066491 |
| Registration expires | 2027-12-31 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (84 FL 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: 2026-09-25
- 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: EmCyte Corporation and 84 Florida peers
- Florida DeviceEstablishmentPulse records like this one: 84
- EmCyte Corporation's amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $16,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for EmCyte Corporation in Fort Myers, Florida?
EmCyte Corporation (Fort Myers, FL), a specification developer (outsources manufacturing), added 2 FDA device listings between 2026-07-15 and 2026-09-25.
How does EmCyte Corporation compare to other Florida DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 41 days old, still within a typical 45-day follow-up window. Its Score of 80/100 puts it among the stronger signals in this feed.
EmCyte Corporation vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| EmCyte Corporation | Fort Myers, FL | 2 | 69th | 2026-09-25 |
| 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: U.S. establishment DeviceEstablishmentPulse: records in Florida
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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.