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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 5 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Bedford Blue Stripe 1
FDA UDI
Class IUnknown
Eyewear By Roi Vecci Gold 1
FDA UDI
Class IActive
Eyewear By Roi Yorn Brown/Teal 1
FDA UDI
Class IActive
Eyewear By Roi Saratov Midnight 1
FDA UDI
Class IActive
Eyewear By Roi Ammons Horn/Crystal 1
FDA UDI
Class IUnknown
Eyewear By Roi Flagami Violet 1
FDA UDI
Class IUnknown
Eyewear By Roi Agatha Tortoise/Peach 1
FDA UDI
Class IActive
Eyewear By Roi Alcova Silver 1
FDA UDI
Class IActive
Eyewear By Roi Santo Domingo Matte Black 1
FDA UDI
Class IActive
Eyewear By Roi Jalen Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Jodie Bordeaux 1
FDA UDI
Class IActive
Eyewear By Roi Carlsbad Matte Black 1
FDA UDI
Class IActive
Eyewear By Roi Angusta Navy 1
FDA UDI
Class IActive
Eyewear By Roi Bax Black 1
FDA UDI
Class IActive
Eyewear By Roi Shakira Wine/Grey 1
FDA UDI
Class IActive
Eyewear By Roi Radicchio Blue/Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Kokia Black 1
FDA UDI
Class IActive
Eyewear By Roi Avignon Lilac 1
FDA UDI
Class IActive
Eyewear By Roi Kumasi Brown 1
FDA UDI
Class IActive
Eyewear By Roi Barron Evergreen 1
FDA UDI
Class IActive
Eyewear By Roi Kumasi Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Rainier Blue 1
FDA UDI
Class IActive
Eyewear By Roi Sala Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Archer Heights Black 1
FDA UDI
Class IActive
Eyewear By Roi Brantford Tortoise/Green 1
FDA UDI
Class IActive
Eyewear By Roi Segovia Navy 1
FDA UDI
Class IUnknown
Eyewear By Roi Reger Grey/Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Senegal Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Prairie View Wine 1
FDA UDI
Class IActive
Eyewear By Roi Harmonie Park Gunmetal 1
FDA UDI
Class IActive
Eyewear By Roi Carlow Wine 1
FDA UDI
Class IActive
Eyewear By Roi Ostia Pink 1
FDA UDI
Class IActive
Eyewear By Roi Ocotillo Blue 1
FDA UDI
Class IActive
Eyewear By Roi Zipoli Brown/Grey 1
FDA UDI
Class IActive
Eyewear By Roi Gayle Lilac 1
FDA UDI
Class IActive
Eyewear By Roi Claremont Sepia 1
FDA UDI
Class IActive
Eyewear By Roi Dauphine Silver 1
FDA UDI
Class IUnknown
Eyewear By Roi Bandera Grey 1
FDA UDI
Class IActive
Eyewear By Roi Cartagena Brown 1
FDA UDI
Class IActive
Eyewear By Roi Minchello Navy/Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Dauphine Silver 1
FDA UDI
Class IActive
Eyewear By Roi Bayou Gold 1
FDA UDI
Class IActive
Eyewear By Roi Giana Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Cannes Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Evie Fuchsia 1
FDA UDI
Class IUnknown
Eyewear By Roi Biarritz Navy 1
FDA UDI
Class IUnknown
Eyewear By Roi Gwendolen Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Ferrari Matte Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Arlette Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Overbrook Gold 1
FDA UDI
Class IActive

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