Perfect Ophthalmic Instruments FZE

FDA Device Registration & Listing · Dubai Dubayy, AE · Registration 3031231776

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
3031231776
FEI Number
3031231776
Entity Name
Perfect Ophthalmic Instruments FZE
City/State/Country
Dubai Dubayy, AE
Establishment Address
B34BS33O303WS63 Jebel Ali Freezone Dubai United Arab Emirates, Dubai Dubayy 000000, AE
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

RUMEX REUSABLE OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS LACHRYMAL DILATOR RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Rumex Instruments DRAPE CLAMP SERREFINE Rumex ophthalmic instruments RUMEX OPHTHALMIC INSTRUMENTS OPHTHALMIC RETRACTOR Injector RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS Markes, Reusable Ophthalmic Instruments GONIOSCOPE GOLDMAN INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC HOOK Rumex ophthalmic instruments RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS LACHRYMAL PROBE RUMEX CARDIOVASCULAR INSTRUMENTS Rumex Ophthalmic Instruments RUMEX OPHTHALMIC INSTRUMENTS BURR FOR ALGER BRUSH OPHTHALMIC SPATULA RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS OPHTHALMIC TREPHINE Depressors RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS Aspirators Diamond Knife Cleaning Pack Markers RUMEX OPHTHALMIC INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS ALGER BRUSH Rumex ophthalmic instruments RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC CANNULA RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC FORCEPS Instruments, Surgical, Cardiovascular RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS Rumex Director OPHTHALMIC CURETTE RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Rumex Probes RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HLN Gauge, Lens, Ophthalmic Ophthalmic Class 1 886.1420 2018-02-07
ISN Cable Physical Medicine Class 1 890.3420 2020-01-15
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2020-02-11
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2006-06-20
HTX Rongeur Orthopedic Class 1 888.4540 2020-01-15
HTD Forceps General, Plastic Surgery Class 1 878.4800 2006-06-20
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2020-02-11
JXS Block, Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2025-03-28
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-06-20
KYD Strip, Schirmer Ophthalmic Class 1 886.1800 2025-12-19
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 2020-01-15
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2020-01-14
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2020-01-15
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2020-01-15
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 2018-02-07
HKS Prism, Gonioscopic Ophthalmic Class 1 886.1660 1998-02-26
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HJL Lens, Condensing, Diagnostic Ophthalmic Class 1 886.1380 2025-12-19
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2020-01-15
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2020-01-15
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2018-02-07
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2006-06-20
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2020-01-15
HPN Magnet, Permanent Ophthalmic Class 1 886.4445 2025-03-17
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2006-06-20
HOF Burr, Corneal, Manual Ophthalmic Class 1 886.4350 2006-06-20
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2006-06-20
LXN Probe, Test, Heart-Valve Cardiovascular Class 1 870.4500 2020-01-15
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2020-01-15
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2018-02-07
HNY Cystotome Ophthalmic Class 1 886.4350 2020-01-15
HXL Mallet General, Plastic Surgery Class 1 878.4800 2020-01-15
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-15
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2018-02-07
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-11-15
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 2018-02-07
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2020-01-15
HMZ Trabeculotome Ophthalmic Class 1 886.4350 2018-02-07
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 2020-01-15
HJZ Crutch, Ptosis Ophthalmic Class 1 886.5600 2020-01-15
HIY Brush, Haidinger, (Including Macular Integrity) Ophthalmic Class 1 886.1090 2006-06-20
HJI Lens, Fundus, Hruby, Diagnostic Ophthalmic Class 1 886.1395 2025-12-19
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2020-01-15
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2009-12-10
EJI Syringe, Cartridge Dental Class 2 872.6770 2020-02-11
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2020-01-15
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2020-01-15
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-15
GAD Retractor General, Plastic Surgery Class 1 878.4800 2020-01-15
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2018-02-07
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2023-04-19
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2006-06-20
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2020-01-15
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2020-01-15
HNK Probe, Trabeculotomy Ophthalmic Class 1 886.4350 2023-04-19
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2020-01-15
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2020-01-15

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
3012185136 RUMEX Baltics SIA Riga, LV
1058726 RUMEX INTERNATIONAL CO. Tampa, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K910471 Baxter Healthcare Corp MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE 1991-03-08
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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009 Becton Dickinson and Company 1
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0308-2026 Alcon Research LLC 1
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number Establishment Name Location
3017857440 HASA OPTIX Brussels Brussels-Capital Region, BE
3004571672 Fischer Surgical Inc. Imperial, MO, US
3008770252 NOVO SURGICAL, INC. Westmont, IL, US
1313525 Bausch & Lomb Incorporated Rochester, NY, US
3007421138 DANYANG GUANHENG OPTICAL, INC Dan Yang Jiangsu, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031231776. Last updated year: 2026. Please use registration number 3031231776 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.