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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 10 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Clarisse Indigo Demi 1
FDA UDI
Class IUnknown
Eyewear By Roi Missoula Rose 1
FDA UDI
Class IActive
Eyewear By Roi Grama Olive 1
FDA UDI
Class IUnknown
Eyewear By Roi Dallas Silver 1
FDA UDI
Class IUnknown
Eyewear By Roi Burano Navy/Grey 1
FDA UDI
Class IActive
Eyewear By Roi Endicott Navy 1
FDA UDI
Class IUnknown
Eyewear By Roi Arwen Brown 1
FDA UDI
Class IActive
Eyewear By Roi Serenity Blue 1
FDA UDI
Class IActive
Eyewear By Roi Pell Blue/Silver 1
FDA UDI
Class IActive
Eyewear By Roi Corsica Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Jujube Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Carlsbad Matte Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Pendelton Gunmetal 1
FDA UDI
Class IUnknown
Eyewear By Roi Elphaba Plum 1
FDA UDI
Class IUnknown
Eyewear By Roi Cafferty Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Janicka Beige/Gold 1
FDA UDI
Class IActive
Eyewear By Roi Durian Black/Red 1
FDA UDI
Class IUnknown
Eyewear By Roi Woodbury Brown 1
FDA UDI
Class IActive
Eyewear By Roi Bruford Crystal 1
FDA UDI
Class IUnknown
Eyewear By Roi Rimava Olive 1
FDA UDI
Class IActive
Eyewear By Roi Adler Black/Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Preston Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Uxmal Forest 1
FDA UDI
Class IUnknown
Eyewear By Roi Tikal Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Barbary Fig Brown Demi 1
FDA UDI
Class IActive
Eyewear By Roi Reine Grey/Coral 1
FDA UDI
Class IActive
Eyewear By Roi Oleander Gunmetal 1
FDA UDI
Class IActive
Eyewear By Roi Asheville Black/Crystal 1
FDA UDI
Class IUnknown
Eyewear By Roi Ravennati Black 1
FDA UDI
Class IActive
Eyewear By Roi Arcadia Black 1
FDA UDI
Class IActive
Eyewear By Roi Reger Grey/Blue 1
FDA UDI
Class IActive
Eyewear By Roi Sandwell Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Yves Blue 1
FDA UDI
Class IActive
Eyewear By Roi Oaklawn Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Lady Fern Black 1
FDA UDI
Class IActive
Eyewear By Roi Fleecydale Wine 1
FDA UDI
Class IActive
Eyewear By Roi Cray Forest 1
FDA UDI
Class IActive
Eyewear By Roi Trixie Brown 1
FDA UDI
Class IActive
Eyewear By Roi Chicory Violet Stripe 1
FDA UDI
Class IActive
Eyewear By Roi Falaise Wine/Gold 1
FDA UDI
Class IUnknown
Eyewear By Roi Rivona Pink 1
FDA UDI
Class IActive
Eyewear By Roi Bunker Matte Grey 1
FDA UDI
Class IActive
Eyewear By Roi Carulli Blue 1
FDA UDI
Class IActive
Eyewear By Roi Prairie View Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Euphrates Ruby 1
FDA UDI
Class IUnknown
Eyewear By Roi Elphaba Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Colleen Peach 1
FDA UDI
Class IActive
Eyewear By Roi Bedford Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Zakros Blue 1
FDA UDI
Class IActive
Eyewear By Roi Tigris Navy 1
FDA UDI
Class IUnknown

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