RUMEX INTERNATIONAL CO.
Registration 1058726FEI 1000307733Tampa, FL
Owner/operator: Rumex International Co.
- Repack or Relabel 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
- 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
- 79
- Added, last 12 months
- 3
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 79
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| FCT | RUMEX OPHTHALMIC INSTRUMENTSHeadlight, Fiberoptic Focusing | Class 2 | 21 CFR 886.4335 | — |
| HOZ | RUMEX OPHTHALMIC INSTRUMENTSSponge, Ophthalmic | Class 2 | 21 CFR 886.4790 | — |
| EJI | RUMEX OPHTHALMIC INSTRUMENTSSyringe, Cartridge | Class 2 | 21 CFR 872.6770 | — |
| GAZ | RUMEX OPHTHALMIC INSTRUMENTSTubing, Noninvasive | Class 2 | 21 CFR 880.6740 | — |
| IQG | RUMEX OPHTHALMIC INSTRUMENTSAdaptor, Holder, Syringe | Class 1 | 21 CFR 890.5050 | — |
| GDO | RUMEX CARDIOVASCULAR INSTRUMENTSApplier, Surgical, Clip | Class 1 | 21 CFR 878.4800 | — |
| JXS | Rumex InstrumentsBlock, Cutting, Ent, Sterile | Class 1 | 21 CFR 874.3540 | — |
| HIY | ALGER BRUSHBrush, Haidinger, (Including Macular Integrity) | Class 1 | 21 CFR 886.1090 | — |
| OHW | Rumex InstrumentsBurr, Corneal, Battery Powered, Rust Ring Removal | Class 1 | 21 CFR 886.4070 | — |
| HOF | BURR FOR ALGER BRUSHBurr, Corneal, Manual | Class 1 | 21 CFR 886.4350 | — |
| ISN | RUMEX OPHTHALMIC INSTRUMENTSCable | Class 1 | 21 CFR 890.3420 | — |
| HOE | RUMEX OPHTHALMIC INSTRUMENTSCaliper, Ophthalmic | Class 1 | 21 CFR 886.4350 | — |
and 67 more on your full dossier
What changed
- Dec 19, 2025Listing added: HJL — Rumex ophthalmic instruments
- Dec 19, 2025Listing added: HJI — Rumex ophthalmic instruments
- Dec 19, 2025Listing added: KYD — Rumex ophthalmic instruments