FDA Registration
Active
🇮🇳 India
EON MEDITECH PVT. LTD.
Reg #: 3023464160
·
FEI: 3023464160
·
Expires 2026
Products
27
Proprietary Names
31
Establishment Types
4
Classifications
27
Registration Details
- Registration Name
- EON MEDITECH PVT. LTD.
- Registration Number
- 3023464160
- FEI Number
- 3023464160
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BL 54, 127, 129, Khanpur Road, Mirapur, Kamrej
- City
- Surat Gujarat
- Country
- IN
Owner / Operator
- Firm Name
- Eon Meditech Pvt. Ltd.
- Operator Number
- 10085729
- Address
- BL 54, 127, 129, Khanpur Road, Mirapur, Kamrej
- City
- Surat
- State
- Gujarat
- Postal Code
- 394320
- Country
- IN
- Correspondent
- Nirav Khunt
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street Suite 103 Miami
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2024-06-08 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2026-01-11 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2023-12-05 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2022-09-29 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2025-12-18 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2024-06-08 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2023-11-27 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 2024-06-08 |
| Catheter, Eustachian, General & Plastic Surgery | GBY | Class 1 | General, Plastic Surgery | No | 2026-01-19 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2023-11-27 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2023-11-27 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2024-06-08 |
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 2023-01-05 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2025-12-18 |
| Dilator, Esophageal, Ent | KCF | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2024-06-08 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2022-08-27 |
| Prosthesis, Adhesive, External | GBJ | Class 1 | General, Plastic Surgery | No | 2024-06-08 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2022-07-27 |
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2023-11-27 |
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
Ear Curette; Jobson horne probes; Cerumen Hook; Rosen Inserter
Ear Suction Tubes; Ear Suction Tube with Suction Controller; Suction Controller; Suction Handles; Fine ends
Suctions Tubes for Throat (single use)
Myringotomy Knife
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device