Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023464160

FEI Number

3023464160

Entity Name

EON MEDITECH PVT. LTD.

City/State/Country

Surat Gujarat, IN

Establishment Address

BL 54, 127, 129, Khanpur Road, Mirapur, Kamrej, Surat Gujarat 394320, IN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Eon Meditech Pvt. Ltd. (Owner Number: 10085729)

Owner / Operator Contact Address

BL 54, 127, 129, Khanpur Road, Mirapur, Kamrej, Surat, IN-GJ 394320, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skin Preparation Pad, Skin Closure Tape SnorOFF Laryngectomy Buttons & Laryngectomy Tubes Ophthalmic sponge; Eye Spears;Points; Corneal Light Shield; LASIK Eye Drain; Eye Wick; LASIK EYE Shield; Instrument Wipe ENT Diamond Burs; ENT Cutting Burs; Shaver Blades Shaver Blade Tubeing Endoscrub Epistaxis Balloon Catheters NOSWICK; PVA Nasal Packs; PVA Nasal Tampons; PVA Nasal Dressing SinoFlo HMEs, Shower guard, StomaGrips, All starter and home kits, TouchFree HMEs Ear Speculas; Nasal Specula Tube Cleaning Brush & Swab EustaFlo Micro Ear Forceps; Nasal Forceps Myringotomy Kit Nasal Suction Tubes with Controller; Sinus Suction Tubes with Controller Cleaning Pad, Adhesion Remover Pad External Nasal Splints; Internal Nasal Splints; Custom Nasal Splints Ear/Nasal Extractor Capsule Salivary ByPass Tube Neck Strap, Tube Holder, Band Gelatino Sponge Chitosorb Nasal Dressing, Chitosorb Ear Dressing Silicone Adhesive Ear Packs, Ear Wicks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2024-06-08
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2026-01-11
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2023-11-27
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2023-12-05
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2022-09-29
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2025-12-18
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2023-11-27
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2024-06-08
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2023-11-27
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2024-06-08
GBY	Catheter, Eustachian, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2026-01-19
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-11-27
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-11-27
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2023-11-27
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2024-06-08
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2023-01-05
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2025-12-18
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-11-27
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2024-06-08
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2022-08-27
GBJ	Prosthesis, Adhesive, External	General, Plastic Surgery	Class 1	878.3750	2024-06-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-07-27
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2023-11-27

Official Correspondent

Nirav Khunt

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Eon Meditech Pvt. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023464160. Last updated year: 2026. Please use registration number 3023464160 when referencing this establishment in official correspondence.