EmCyte Corporation
Registration 1066491FEI 3003429569FORT MYERS, FL
Owner/operator: EmCyte Corporation
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
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- Dec 1Our pay-by date30 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 15
- Added, last 12 months
- 1
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 15
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| ORG | Centrepid Platelet ConcentratorPlatelet And Plasma Separator For Bone Graft Handling | Class 2 | 21 CFR 864.9245 | BK130079 |
| FMF | PUREBMC SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 120mLSyringe, Piston | Class 2 | 21 CFR 880.5860 | K183205 |
| MUU | PROGENIKINE CONCENTRATING SYSTEMSystem, Suction, Lipoplasty | Class 2 | 21 CFR 878.5040 | K191564 |
| IQG | BONE GRAFT SYRINGE HOLDERAdaptor, Holder, Syringe | Class 1 | 21 CFR 890.5050 | — |
| KSO | EXECUTIVE SERIES CENTRIFUGECentrifuge, Blood-Bank For In Vitro Diagnostic Use | Class 1 | 21 CFR 864.9275 | — |
| JQC | SAPPHIRE SERIES CENTRIFUGECentrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | 21 CFR 862.2050 | — |
| JQC | ABSOLUTEPRP CONCENTRATING SYSTEMCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | 21 CFR 862.2050 | BK050055 |
| JQC | ABSOLUTEBMC CONCENTRATING SYSTEMCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | 21 CFR 862.2050 | K070666 |
| JQC | PUREBMC SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 120mLCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | 21 CFR 862.2050 | K183205 |
| JQC | PURE TWO CONCENTRATORCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | 21 CFR 862.2050 | K024080 |
| JQC | PUREPRP SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 120mLCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | 21 CFR 862.2050 | BK190317 |
| GAA | ASPIRE Bone Marrow Harvesting SystemNeedle, Aspiration And Injection, Disposable | Class 1 | 21 CFR 878.4800 | — |
and 3 more on your full dossier
What changed
- Jul 15, 2026Listing added: OTQ — RegeniSTAT AI Platelet Analyzer