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Sign in to claim this brandEON MEDITECH PRIVATE LIMITED
US
Last updated May 23, 2026
What EON MEDITECH PRIVATE LIMITED makes
The company manufactures single-use and reusable medical devices for otolaryngology (ENT) and ophthalmology, including nasal mucosa dressings, ear canal suction tubes, diamond and metal/carbide burs, gelatin haemostatic sponges, ear wicks, ophthalmic sponges, and nasal biopsy curettes. Notable products include disposable suction tubes for the ear, fine diamond burs for ENT procedures, thermoplastic splint kits, and gelatin-based sponges for haemostasis.
All listed devices fall under Class I regulatory classification in the US, with authorisation via the FDA’s Unique Device Identifier (UDI) database. The company’s portfolio is registered under the FDA’s UDI system, ensuring compliance with US medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does EON Meditech Private Limited manufacture?
EON Meditech Private Limited specializes in medical devices primarily for otolaryngology (ENT) and ophthalmology. Their portfolio includes single-use and reusable products like nasal mucosa dressings, ear canal suction handles (such as disposable suction tubes for the ear), diamond and metal/carbide ENT burs, gelatin haemostatic sponges, ear wicks, ophthalmic sponges, and nasal biopsy curettes. These devices are designed to support procedures in these specialized medical fields.
Where is EON Meditech Private Limited based, and how does that affect their regulatory compliance?
EON Meditech Private Limited is based in the US. Since they operate within the US market, their devices must comply with US regulatory requirements. Their products are registered under the FDA’s Unique Device Identifier (UDI) system, which is a key compliance measure for medical devices in the US. This ensures traceability and adherence to US medical device regulations.
Which regulatory registries list EON Meditech Private Limited’s devices, and why is this important?
EON Meditech Private Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides a standardized way to identify medical devices throughout their distribution and use. Listing in the UDI system helps ensure compliance with US regulations, supports tracking for safety monitoring, and facilitates transparency in the medical device supply chain.
How are EON Meditech Private Limited’s devices classified under US regulations, and what does this mean?
All of EON Meditech Private Limited’s listed devices fall under Class I regulatory classification in the US. Class I devices are generally considered to pose the lowest risk and typically do not require pre-market approval, though they still must comply with general controls (e.g., proper labeling, manufacturing practices) and may need registration with the FDA. This classification reflects that their products, such as suction tubes, burs, and sponges, are designed for low-to-moderate risk applications in ENT and ophthalmology.
Why are some of EON Meditech Private Limited’s devices labeled as single-use, and how does this impact their regulatory status?
EON Meditech Private Limited manufactures both single-use and reusable devices, with many of their products—such as suction tubes, burs, and sponges—intended for single-use only. Single-use devices are designed to be discarded after one procedure to reduce infection risks and ensure sterility. While this classification does not change their Class I regulatory status, it influences manufacturing controls, sterilization requirements, and labeling (e.g., clear instructions for disposal). The FDA’s UDI system accounts for these distinctions to maintain traceability and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 930270428
Catalogue (382)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OSSEOUS Suction Tube for Ear-Disposable | EI153080 | FDA UDI | Class I | Active |
| OSSEOUS Suction Tube for Ear-Disposable | EI152570 | FDA UDI | Class I | Active |
| OSSEOUS Frazier Suction Tube for Ear-Disposable | EI151070-F | FDA UDI | Class I | Active |
| OSSEOUS Silicone Sheeting Blue Folios | E3146UUS-206B | FDA UDI | Class I | Active |
| Osseous | ENOZ-OK-10 | FDA UDI | Class I | Active |
| OSSEOUS Frazier Suction Tube for Ear-Disposable | EI1510100-F | FDA UDI | Class I | Active |
| Osseous | E7188-OC | FDA UDI | Class I | Active |
| Osseous | E7186-C | FDA UDI | Class I | Active |
| Osseous | E7181-OC | FDA UDI | Class I | Active |
| OSSEOUS PVA Eye Wick | E7149 | FDA UDI | Class I | Active |
| Osseous | E7162-O | FDA UDI | Class I | Active |
| Osseous | E7184-O | FDA UDI | Class I | Active |
| Osseous | E7189-O | FDA UDI | Class I | Active |
| OSSEOUS Burs-Course Diamond | EI2105CD | FDA UDI | Class I | Active |
| OSSEOUS Suction Tube for Ear-Disposable | EI154080 | FDA UDI | Class I | Active |
| Osseous | E7190-L | FDA UDI | Class I | Active |
| OSSEOUS Salivary by Pass Tube | E31412W | FDA UDI | Class I | Active |
| OSSEOUS Burs-Tungsten Carbide | EI2140TC | FDA UDI | Class I | Active |
| OSSEOUS Zoellner Suction Tube for Ear-Disposable | EI151080-Z | FDA UDI | Class I | Active |
| Osseous | E7163-O | FDA UDI | Class I | Active |
| Osseous | E7169-OC | FDA UDI | Class I | Active |
| Osseous | E3130930 | FDA UDI | Class I | Active |
| OSSEOUS Zoellner Suction Tube for Ear-Disposable | EI1510100-Z | FDA UDI | Class I | Active |
| OSSEOUS Zoellner Suction Tube for Ear-Disposable | EI151780-Z | FDA UDI | Class I | Active |
| Osseous | E3131230 | FDA UDI | Class I | Active |
| OSSEOUS Zoellner Suction Tube for Ear-Disposable | EI1517100-Z | FDA UDI | Class I | Active |
| OSSEOUS Suction Tubes for Ear Disposable | EI152070-F | FDA UDI | Class I | Active |
| OSSEOUS PVA Eye Drain Large | E7148 | FDA UDI | Class I | Active |
| OSSEOUS Frazier Suction Tube for Ear-Disposable | EI151270-F | FDA UDI | Class I | Active |
| OSSEOUS GEL FOAM Sheet | E9115200 | FDA UDI | Class I | Active |
| OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type | EI2208 | FDA UDI | Class I | Active |
| OSSEOUS Frazier Suction Tube for Ear-Disposable | EI150470-F | FDA UDI | Class I | Active |
| OSSEOUS Fluoroplastic Sheet | E3146USF | FDA UDI | Class I | Active |
| OSSEOUS Burs-Tungsten Carbide | EI2155TC | FDA UDI | Class I | Active |
| Osseous | ENOZ-OL-10 | FDA UDI | Class I | Active |
| OSSEOUS Burs-Tungsten Carbide | EI2170TC | FDA UDI | Class I | Active |
| Osseous | E3131415 | FDA UDI | Class I | Active |
| OSSEOUS Salivary by Pass Tube | E31410C | FDA UDI | Class I | Active |
| OSSEOUS Burs-stainless Steel | EI2105SS | FDA UDI | Class I | Active |
| OSSEOUS Burs-Tungsten Carbide | EI2115TC | FDA UDI | Class I | Active |
| Osseous | E7184-SC | FDA UDI | Class I | Active |
| Osseous | E7186-L | FDA UDI | Class I | Active |
| OSSEOUS Zoellner Suction Tube for Ear-Disposable | EI1516100-Z | FDA UDI | Class I | Active |
| OSSEOUS Silicone Sheeting Clear Folios | E3146UUS-1515C | FDA UDI | Class I | Active |
| OSSEOUS Blade-Curved Sinus Blades - M Type | EI2205 | FDA UDI | Class I | Active |
| OSSEOUS PVA Corneal Light Shield | E7144 | FDA UDI | Class I | Active |
| Osseous | E7193-C | FDA UDI | Class I | Active |
| OSSEOUS Gelatin Sponge Sterifen | E91108040 | FDA UDI | Class I | Active |
| OSSEOUS Suction Tubes for Ear Disposable | EI152080-F | FDA UDI | Class I | Active |
| Osseous | E3130922 | FDA UDI | Class I | Active |
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