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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 2 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Fiyero Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Chico Shiny Gunmetal 1
FDA UDI
Class IUnknown
Eyewear By Roi Workman Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Missoula Rose 1
FDA UDI
Class IUnknown
Eyewear By Roi Alinda Blue/Pattern 1
FDA UDI
Class IActive
Eyewear By Roi Window Rock Crystal Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Dunlop Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Saratov Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Kumasi Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Kitty Hawk Blue/Green 1
FDA UDI
Class IUnknown
Eyewear By Roi Brielle Gold 1
FDA UDI
Class IActive
Eyewear By Roi Palenque Purple 1
FDA UDI
Class IUnknown
Eyewear By Roi Dunlop Tortoise/Crystal 1
FDA UDI
Class IActive
Eyewear By Roi Valentine Black/Rose 1
FDA UDI
Class IActive
Eyewear By Roi Bogan Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Bez Tortoise 1
FDA UDI
Class IActive
Eyewear By Roi Byblos Grey 1
FDA UDI
Class IActive
Eyewear By Roi Shangri La Hematite 1
FDA UDI
Class IActive
Eyewear By Roi Price Silver 1
FDA UDI
Class IActive
Eyewear By Roi Viola Rose Multi 1
FDA UDI
Class IActive
Eyewear By Roi Pomeroy Red/Gold 1
FDA UDI
Class IActive
Eyewear By Roi Taylor Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Burleson Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Nicolette Demi/Pink 1
FDA UDI
Class IUnknown
Eyewear By Roi Overbrook Gunmetal 1
FDA UDI
Class IActive
Eyewear By Roi Trixie Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Silverdale Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Lewisville Black 1
FDA UDI
Class IActive
Eyewear By Roi Annecy Rose 1
FDA UDI
Class IActive
Eyewear By Roi Laelia Matte Plum 1
FDA UDI
Class IActive
Eyewear By Roi Ixtapa Black/Purple 1
FDA UDI
Class IUnknown
Eyewear By Roi Tommy Navy 1
FDA UDI
Class IActive
Eyewear By Roi Benin City Navy 1
FDA UDI
Class IUnknown
Eyewear By Roi Byblos Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Harrell Black/Blue 1
FDA UDI
Class IActive
Eyewear By Roi Kimmswick Wine 1
FDA UDI
Class IActive
Eyewear By Roi Cornwall Brown 1
FDA UDI
Class IActive
Eyewear By Roi Retsil Rose 1
FDA UDI
Class IUnknown
Eyewear By Roi Asheville Tortoise/Mint 1
FDA UDI
Class IActive
Eyewear By Roi Kimbrough Green 1
FDA UDI
Class IActive
Eyewear By Roi Filaree Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Hill City Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Katya Violet 1
FDA UDI
Class IActive
Eyewear By Roi Radicchio Rose 1
FDA UDI
Class IActive
Eyewear By Roi Watts Shiny Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Gretchen Teal/Green 1
FDA UDI
Class IActive
Eyewear By Roi Heloise Teal 1
FDA UDI
Class IActive
Eyewear By Roi Morenci Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Archer Heights Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Mystic Black 1
FDA UDI
Class IActive

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