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Eyewear By Roi, Limited

US

Last updated May 24, 2026

What Eyewear By Roi, Limited makes

Eyewear By Roi, Limited manufactures spectacle frames designed for corrective and fashion eyewear. The frames include a variety of styles, such as the Banner Elk, Carondelet, Isla, Stitt, Tora, Dale, Coronis, Sokolov, Burleson, Dexheimer, and Moroni, each available in different color combinations.

The company’s spectacle frames fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer 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 Eyewear By Roi, Limited manufacture?

Eyewear By Roi, Limited specializes in spectacle frames, which are primarily designed for both corrective vision and fashion purposes. These frames are intended to hold eyeglasses in place for visual correction or aesthetic use, aligning with the company’s focus on eyewear solutions.

Where is Eyewear By Roi, Limited based, and how does that affect its regulatory standing?

Eyewear By Roi, Limited is based in the United States. Since the company’s devices are subject to FDA regulations, its location ensures compliance with U.S. medical device laws, including mandatory registration and listing requirements for Class I devices in the FDA’s Unique Device Identification (UDI) system.

Which regulatory registries or databases list Eyewear By Roi, Limited’s spectacle frames?

Eyewear By Roi, Limited’s spectacle frames are listed in the FDA’s Unique Device Identification (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements for Class I devices.

How are Eyewear By Roi, Limited’s spectacle frames classified under FDA regulations?

Eyewear By Roi, Limited’s spectacle frames are classified as FDA Class I medical devices. This classification applies because the frames are low-risk, non-invasive products primarily used for vision correction or fashion, requiring general controls to ensure safety and performance without additional premarket review.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
eyewearbyroi.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(480)905-8020
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
177953189

Catalogue (1324)

Page 1 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Belcalis Black/White 1
FDA UDI
Class IUnknown
Eyewear By Roi Banner Elk Black 1
FDA UDI
Class IActive
Eyewear By Roi Carondelet Grey/Orange 1
FDA UDI
Class IActive
Eyewear By Roi Isla Brown Purple 1
FDA UDI
Class IActive
Eyewear By Roi Stitt Grey 1
FDA UDI
Class IActive
Eyewear By Roi Tora Black 1
FDA UDI
Class IActive
Eyewear By Roi Dale Dark Gunmetal 1
FDA UDI
Class IActive
Eyewear By Roi Coronis Faded Rose 1
FDA UDI
Class IActive
Eyewear By Roi Sokolov Grey 1
FDA UDI
Class IActive
Eyewear By Roi Isla Black Pink 1
FDA UDI
Class IActive
Eyewear By Roi Burleson Grey 1
FDA UDI
Class IActive
Eyewear By Roi Dexheimer Black 1
FDA UDI
Class IActive
Eyewear By Roi Moroni Ruby 1
FDA UDI
Class IActive
Eyewear By Roi Ostia Pink 1
FDA UDI
Class IUnknown
Eyewear By Roi Fiyero Tortoise 1
FDA UDI
Class IActive
Eyewear By Roi Cooder Tortoise/Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Odem Grey 1
FDA UDI
Class IActive
Eyewear By Roi Daphne Grape 1
FDA UDI
Class IActive
Eyewear By Roi Foldwing Snake/Gold 1
FDA UDI
Class IUnknown
Eyewear By Roi Patchouli Blue/Tortoise 1
FDA UDI
Class IActive
Eyewear By Roi Arcadia Navy 1
FDA UDI
Class IActive
Eyewear By Roi Scrim Black 1
FDA UDI
Class IActive
Eyewear By Roi Cherie Pink Tortoise 1
FDA UDI
Class IActive
Eyewear By Roi Oleander Soft Burgundy 1
FDA UDI
Class IUnknown
Eyewear By Roi Torenia Black/Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Alameda Marsala 1
FDA UDI
Class IActive
Eyewear By Roi Marble Falls Khaki 1
FDA UDI
Class IUnknown
Eyewear By Roi Morgan Dark Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Banks Crystal/Tortoise 1
FDA UDI
Class IActive
Eyewear By Roi Burbank Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Tora Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Alamosa Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Cycad Lime 1
FDA UDI
Class IActive
Eyewear By Roi Cajun Brown 1
FDA UDI
Class IActive
Eyewear By Roi Lynott Black 1
FDA UDI
Class IActive
Eyewear By Roi Algernon Navy 1
FDA UDI
Class IActive
Eyewear By Roi Dean Grey 1
FDA UDI
Class IActive
Eyewear By Roi Bedford Blue Stripe 1
FDA UDI
Class IActive
Eyewear By Roi Vika Caramel 1
FDA UDI
Class IActive
Eyewear By Roi Banks Brown Demi/Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Cajun Violet 1
FDA UDI
Class IUnknown
Eyewear By Roi Bez Crystal Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Hill City Grey 1
FDA UDI
Class IActive
Eyewear By Roi Bilbo Grey 1
FDA UDI
Class IActive
Eyewear By Roi Orchard Beach Grape 1
FDA UDI
Class IActive
Eyewear By Roi Bougainvillea Sand 1
FDA UDI
Class IUnknown
Eyewear By Roi Chayote Plum 1
FDA UDI
Class IActive
Eyewear By Roi Bridgeport Blue Fade 1
FDA UDI
Class IActive
Eyewear By Roi Zimmer Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Night Owl Black Pattern 1
FDA UDI
Class IUnknown

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