VICTORCH MEDITEK, INC.
Registration 2032364FEI 3003323921San Diego, CA
Owner/operator: VICTORCH MEDITEK INC
- Manufacture Device in the United States for Export Only
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
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 15
- Added, last 12 months
- 15
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 |
|---|---|---|---|---|
| NAF | PSA Rapid TestAntigen(Complexed),Prostate Specific,(Cpsa)Added Jul 2, 2026 | Class 3 | — | — |
| OSL | Fecal occult Blood (FOB) Rapid TestControl, Fecal Occult BloodAdded Jul 2, 2026 | Class 2 | 21 CFR 864.6550 | — |
| HCG | HCG pregnancy Urine Rapid Test, HCG Midstream Rapid TestDevice, Neurovascular EmbolizationAdded Jul 2, 2026 | Class 2 | 21 CFR 882.5950 | — |
| LIP | Treponema Ab Rapid TestEnzyme Linked Immunoabsorption Assay, Treponema PallidumAdded Jul 2, 2026 | Class 2 | 21 CFR 866.3830 | — |
| LOJ | AFP Rapid TestKit, Test,Alpha-Fetoprotein For Testicular CancerAdded Jul 2, 2026 | Class 2 | 21 CFR 866.6010 | — |
| SCA | Covid-19/Flu A/Alu B/RSV Rapid TestMulti-Analyte Respiratory Virus Antigen Detection TestAdded Jul 2, 2026 | Class 2 | 21 CFR 866.3987 | — |
| DJC | FYL/MET/COC DOA Rapid TestThin Layer Chromatography, MethamphetamineAdded Jul 2, 2026 | Class 2 | 21 CFR 862.3610 | — |
| DDG | FOB/TRF Rapid TestTransferrin, Antigen, Antiserum, ControlAdded Jul 2, 2026 | Class 2 | 21 CFR 866.5880 | — |
| FRG | Hemostatic Patch BagWrap, SterilizationAdded Jun 30, 2026 | Class 2 | 21 CFR 880.6850 | — |
| LKI | Chlamydia Rapid TestAntisera, Fluorescent, Chlamydia Spp.Added Jul 2, 2026 | Class 1 | 21 CFR 866.3120 | — |
| KXG | Nasopharyngeal SwabApplicator, Absorbent Tipped, SterileAdded Jul 2, 2026 | Class 1 | 21 CFR 880.6025 | — |
| LQP | H. pylori Antigen Rapid TestCampylobacter Spp.Added Jul 2, 2026 | Class 1 | 21 CFR 866.3110 | — |
and 3 more on your full dossier
What changed
- Jul 2, 2026Listing added: NAF — PSA Rapid Test
- Jul 2, 2026Listing added: OSL — Fecal occult Blood (FOB) Rapid Test
- Jul 2, 2026Listing added: HCG — HCG pregnancy Urine Rapid Test, HCG Midstream Rapid Test
- Jul 2, 2026Listing added: LIP — Treponema Ab Rapid Test
- Jul 2, 2026Listing added: LOJ — AFP Rapid Test
- Jul 2, 2026Listing added: SCA — Covid-19/Flu A/Alu B/RSV Rapid Test
- Jul 2, 2026Listing added: DJC — FYL/MET/COC DOA Rapid Test
- Jul 2, 2026Listing added: DDG — FOB/TRF Rapid Test
- Jun 30, 2026Listing added: FRG — Hemostatic Patch Bag
- Jul 2, 2026Listing added: LKI — Chlamydia Rapid Test
- Jul 2, 2026Listing added: KXG — Nasopharyngeal Swab
- Jul 2, 2026Listing added: LQP — H. pylori Antigen Rapid Test
- Jun 30, 2026Listing added: JOK — Emergency First Aid Bag
- Jul 2, 2026Listing added: JJX — CEA Rapid Test
- Jul 2, 2026Listing added: NGE — LH Rapid test