RUMEX Baltics SIA

FDA Device Registration & Listing · Riga, LV · Registration 3012185136

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012185136
FEI Number
3012185136
Entity Name
RUMEX Baltics SIA
City/State/Country
Riga, LV
Establishment Address
46, Robezu str., Riga LV-1004, LV
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Rumex International Co. (Owner Number: 9011770)
Owner / Operator Contact Address
14240 Carlson Circle, Building K, Suite 8, Tampa, FL 33626, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LACHRYMAL PROBE RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC KNIFE RUMEX REUSABLE OPHTHALMIC INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS ALGER BRUSH RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Rumex ophthalmic instruments RUMEX OPHTHALMIC INSTRUMENTS BURR FOR ALGER BRUSH RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC CANNULA GONIOSCOPE GOLDMAN INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS Rumex ophthalmic instruments RUMEX OPHTHALMIC INSTRUMENTS Rumex Director RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS FIXATION RING RING OPTHALMIC Markers EYE SHIELD RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS LACHRYMAL DILATOR Depressors Aspirators RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS OPHTHALMIC SPECULA OPHTHALMIC SPECULUM RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS OPHTHALMIC SPATULA RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Scissors, General RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Rumex ophthalmic instruments RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC HOOK Rumex Instruments RUMEX CARDIOVASCULAR INSTRUMENTS DRAPE CLAMP SERREFINE Rumex Probes RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC FORCEPS RUMEX CARDIOVASCULAR INSTRUMENTS Dissector Markes, Reusable Ophthalmic Instruments RUMEX OPHTHALMIC INSTRUMENTS STERILIZATION TRAYS OPHTHALMIC TREPHINE Injector Scalpel RUMEX OPHTHALMIC INSTRUMENTS Diamond Knife Cleaning Pack FORCEPS RUMEX OPHTHALMIC INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2006-06-20
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HMZ Trabeculotome Ophthalmic Class 1 886.4350 2018-02-07
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2018-02-07
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2020-01-15
HIY Brush, Haidinger, (Including Macular Integrity) Ophthalmic Class 1 886.1090 2006-06-20
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2020-01-15
HJL Lens, Condensing, Diagnostic Ophthalmic Class 1 886.1380 2025-12-19
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2020-01-15
HOF Burr, Corneal, Manual Ophthalmic Class 1 886.4350 2006-06-20
HXL Mallet General, Plastic Surgery Class 1 878.4800 2020-01-15
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HKS Prism, Gonioscopic Ophthalmic Class 1 886.1660 1998-02-26
HTX Rongeur Orthopedic Class 1 888.4540 2020-01-15
HJI Lens, Fundus, Hruby, Diagnostic Ophthalmic Class 1 886.1395 2025-12-19
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2020-01-15
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2023-04-19
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2020-01-15
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2020-01-15
ISN Cable Physical Medicine Class 1 890.3420 2020-01-15
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2020-01-15
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 1998-02-26
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 2018-02-07
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2006-06-20
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2020-01-15
EJI Syringe, Cartridge Dental Class 2 872.6770 2020-02-11
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2006-06-20
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2018-02-07
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2018-02-07
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2020-01-15
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-15
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 1998-02-26
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 2020-01-15
HTD Forceps General, Plastic Surgery Class 1 878.4800 2006-06-20
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2020-01-15
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2006-06-20
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 1996-02-01
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-15
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HNY Cystotome Ophthalmic Class 1 886.4350 2020-01-15
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2006-06-20
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2020-01-15
FCT Headlight, Fiberoptic Focusing Ophthalmic Class 2 886.4335 2020-01-15
KYD Strip, Schirmer Ophthalmic Class 1 886.1800 2025-12-19
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
JXS Block, Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2025-03-28
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2020-01-15
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-06-20
HNK Probe, Trabeculotomy Ophthalmic Class 1 886.4350 2023-04-19
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2020-01-15
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-14
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 2018-02-07
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2020-02-11
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2006-06-20
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2020-01-14
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-08-11
HJZ Crutch, Ptosis Ophthalmic Class 1 886.5600 2020-01-15
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-11-15
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-06-20
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2020-02-11
HLN Gauge, Lens, Ophthalmic Ophthalmic Class 1 886.1420 2018-02-07

Official Correspondent

Inessa Cellentani

US Agent Details

Inessa Cellentani Business: RUMEX INTERNATIONAL CO. Email: regulatory@rumex.com Phone: (727) 5359600

Related Public Records

Same Entity

Rumex International Co.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3031231776 Perfect Ophthalmic Instruments FZE Dubai Dubayy, AE
1058726 RUMEX INTERNATIONAL CO. Tampa, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K910471 Baxter Healthcare Corp MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE 1991-03-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012185136. Last updated year: 2026. Please use registration number 3012185136 when referencing this establishment in official correspondence.
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