FDA Registration
Active
🇺🇸 United States
RUMEX INTERNATIONAL CO.
Reg #: 1058726
·
FEI: 1000307733
·
Expires 2026
Products
79
Proprietary Names
38
Establishment Types
1
Classifications
79
Registration Details
- Registration Name
- RUMEX INTERNATIONAL CO.
- Registration Number
- 1058726
- FEI Number
- 1000307733
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 14240 Carlson Circle, Building K, Suite 8
- City
- Tampa
- State
- FL
- ZIP
- 33626
- Country
- US
Owner / Operator
- Firm Name
- Rumex International Co.
- Operator Number
- 9011770
- Address
- 14240 Carlson Circle, Building K, Suite 8
- City
- Tampa
- State
- FL
- Postal Code
- 33626
- Country
- US
- Correspondent
- Inessa Cellentani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2020-02-11 |
| Block, Cutting, Ent, Sterile | JXS | Class 1 | Ear, Nose, Throat | No | 2025-03-28 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2006-06-20 |
| Headlight, Fiberoptic Focusing | FCT | Class 2 | Ophthalmic | No | 2020-01-15 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2006-06-20 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2025-04-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1996-02-01 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2020-01-15 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2006-06-20 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2020-01-15 |
| Strip, Schirmer | KYD | Class 1 | Ophthalmic | No | 2025-12-19 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2006-06-20 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2023-04-19 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 1998-02-26 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2020-02-11 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2023-04-19 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2018-02-07 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2018-02-07 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2025-12-19 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2006-06-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-11-15 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2020-01-14 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2020-01-15 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2006-06-20 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2009-12-10 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2020-02-11 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Crutch, Ptosis | HJZ | Class 1 | Ophthalmic | No | 2020-01-15 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2020-01-14 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Trabeculotome | HMZ | Class 1 | Ophthalmic | No | 2018-02-07 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2006-06-20 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2020-01-15 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2006-06-20 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2020-01-15 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2006-06-20 |
| Brush, Haidinger, (Including Macular Integrity) | HIY | Class 1 | Ophthalmic | No | 2006-06-20 |
| Cable | ISN | Class 1 | Physical Medicine | No | 2020-01-15 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2020-01-15 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2018-02-07 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2006-06-20 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2006-06-20 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2025-04-10 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 1998-02-26 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2006-06-20 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2020-01-15 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2018-02-07 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2006-06-20 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 2020-01-15 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1998-02-26 |
| Magnet, Permanent | HPN | Class 1 | Ophthalmic | No | 2025-03-17 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Probe, Test, Heart-Valve | LXN | Class 1 | Cardiovascular | No | 2020-01-15 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2020-01-15 |
| Lens, Fundus, Hruby, Diagnostic | HJI | Class 1 | Ophthalmic | No | 2025-12-19 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2018-02-07 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2025-03-17 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2006-06-20 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2020-01-15 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2006-06-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2020-01-15 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2006-06-20 |
Proprietary Names
RUMEX OPHTHALMIC INSTRUMENTS
Rumex Instruments
OPHTHALMIC TREPHINE
RUMEX CARDIOVASCULAR INSTRUMENTS
RUMEX OPHTHALMIC HOOK
Rumex ophthalmic instruments
OPHTHALMIC CURETTE
Rumex Probes
GONIOSCOPE
GOLDMAN INSTRUMENTS
Rumex Director
RUMEX REUSABLE OPHTHALMIC INSTRUMENTS
Markes, Reusable Ophthalmic Instruments
Diamond Knife Cleaning Pack
Dissector
DRAPE CLAMP
SERREFINE
LACHRYMAL DILATOR
Instruments, Surgical, Cardiovascular
Injector
OPHTHALMIC SPATULA
EYE SHIELD
ALGER BRUSH
RUMEX OPHTHALMIC FORCEPS
Scissors, General
Rumex Intsruments
FIXATION RING
RING OPTHALMIC
RUMEX OPHTHALMIC CANNULA
OPHTHALMIC RETRACTOR
OPHTHALMIC SPECULA
OPHTHALMIC SPECULUM
Rumex Ophthalmic Instruments
STERILIZATION TRAYS
FORCEPS
LACHRYMAL PROBE
BURR FOR ALGER BRUSH
RUMEX OPHTHALMIC KNIFE
Establishment Types
Repack or Relabel Medical Device