NEO MEDICAL INC.
Registration 3007207906FEI 3007207906Sparks, NV
Owner/operator: Neo Medical Inc.
- 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
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 23Holiday week8 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 23
- Added, last 12 months
- 0
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 23
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| CAZ | Continuous Plexus Anesthesia KitAnesthesia Conduction Kit | Class 2 | 21 CFR 868.5140 | K994059 |
| CAZ | Pandin Continous Nerve CatheterAnesthesia Conduction Kit | Class 2 | 21 CFR 868.5140 | K022752 |
| LJS | SilcathCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | 21 CFR 880.5970 | K834091 |
| LJS | Trocar TunnelerCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | 21 CFR 880.5970 | K951098 |
| LJS | Neo-Magic & V-Cath Dual Lumen ESP CathetersCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | 21 CFR 880.5970 | K953300 |
| LJS | Power V-CathCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | 21 CFR 880.5970 | K071875 |
| FOZ | Neo-Magic & V-Cath PICCsCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K964966 |
| FOZ | Sharps Safety Over The Needle Catheters & IntroducersCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K022099 |
| FOZ | Neo-Magic EPIV & V-Cath Midline CathetersCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K983916 |
| FOZ | Centrasil Central Venous CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K881215 |
| FOZ | Poly PICC V-cath & Neo-MagicCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K033853 |
| DQY | V-Cath & Neo-MagicCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | K881504 |
and 11 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.