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Sign in to claim this brandWhat Innova Medical Ophthalmics Inc makes
Innova Medical Ophthalmics Inc manufactures battery-powered corneal bur systems designed for ophthalmic procedures. Their primary product, the Amoils Epithelial Scrubber, is used for corneal epithelial debridement and preparation in surgical settings.
The Amoils Epithelial Scrubber is classified as a Class I medical device and is listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 Innova Medical Ophthalmics Inc manufacture?
Innova Medical Ophthalmics Inc specializes in battery-powered corneal bur systems. Their primary focus is on devices used for ophthalmic procedures, specifically the Amoils Epithelial Scrubber, which is designed for corneal epithelial debridement and preparation during surgery. These devices are tailored for precision tasks in eye surgery.
Where is Innova Medical Ophthalmics Inc based?
Innova Medical Ophthalmics Inc is headquartered in the United States. This location aligns with regulatory frameworks governing medical devices in the country, ensuring compliance with local standards and guidelines.
Which regulatory registries list devices manufactured by Innova Medical Ophthalmics Inc?
Devices from Innova Medical Ophthalmics Inc, such as the Amoils Epithelial Scrubber, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability.
How are devices from Innova Medical Ophthalmics Inc classified under regulatory standards?
The Amoils Epithelial Scrubber, a key product from Innova Medical Ophthalmics Inc, is classified as a Class I medical device. This classification is typically assigned to devices posing minimal risk to patients, such as those used for low-risk procedures like corneal debridement, where the risk of harm is low.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- Website
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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
- 249464702
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amoils Epithelial Scrubber | Hyperopic XL Pack of 25 | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Amoils Handle Charger (230V) | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Amoils Power Handle, Neck & Charger - Kit (120V) | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Amoils Power Handle, Neck & Charger - Kit (230V) | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Hyperopic Pack of 25 | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Amoils Handle Charger (120V) | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Amoils Power Handle | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Myopic Pack of 25 | FDA UDI | Class I | Active |
| Amoils Epithelial Scrubber | Amoils Neck Mount | FDA UDI | Class I | Active |
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