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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 3 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Pella Rose /gold 1
FDA UDI
Class IActive
Eyewear By Roi Lily Valley Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Shalimar Faded Rose 1
FDA UDI
Class IUnknown
Eyewear By Roi Watts Gunmetal 1
FDA UDI
Class IUnknown
Eyewear By Roi Claremont Sepia 1
FDA UDI
Class IUnknown
Eyewear By Roi Golden Valley Gunmetal 1
FDA UDI
Class IUnknown
Eyewear By Roi Atlantis Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Clarisse Plum Demi 1
FDA UDI
Class IUnknown
Eyewear By Roi Esme Crystal/Pink 1
FDA UDI
Class IUnknown
Eyewear By Roi Ferrari Matte Black 1
FDA UDI
Class IActive
Eyewear By Roi Ezra Black 1
FDA UDI
Class IActive
Eyewear By Roi Kiltie Plum 1
FDA UDI
Class IActive
Eyewear By Roi Surfside Crystal 1
FDA UDI
Class IUnknown
Eyewear By Roi Margao Grey 1
FDA UDI
Class IActive
Eyewear By Roi Rivona Pink 1
FDA UDI
Class IUnknown
Eyewear By Roi Yves Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Parodia Plum 1
FDA UDI
Class IActive
Eyewear By Roi Morenci Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Pella Rose /gold 1
FDA UDI
Class IUnknown
Eyewear By Roi Gretchen Teal/Green 1
FDA UDI
Class IUnknown
Eyewear By Roi Tippett Indigo 1
FDA UDI
Class IActive
Eyewear By Roi Tigris Navy 1
FDA UDI
Class IActive
Eyewear By Roi Franklinia Black 1
FDA UDI
Class IActive
Eyewear By Roi Wintory Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Sigillaria Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Darby Gold 1
FDA UDI
Class IActive
Eyewear By Roi Brielle Gold 1
FDA UDI
Class IUnknown
Eyewear By Roi Banks Brown Demi/Blue 1
FDA UDI
Class IActive
Eyewear By Roi Buckingham Teal Demi 1
FDA UDI
Class IUnknown
Eyewear By Roi Tula Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Taylor Brown 1
FDA UDI
Class IActive
Eyewear By Roi Myrrh Black 1
FDA UDI
Class IActive
Eyewear By Roi Paros Crystal Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Bardstown Black/Silver 1
FDA UDI
Class IActive
Eyewear By Roi Dyersville Blue Grey 1
FDA UDI
Class IActive
Eyewear By Roi Gilels Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Nicolette Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Senegal Brown 1
FDA UDI
Class IActive
Eyewear By Roi Maggiore Navy 1
FDA UDI
Class IUnknown
Eyewear By Roi Angel Oak Neutral 1
FDA UDI
Class IUnknown
Eyewear By Roi Myrrh Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Woodbury Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Remi Peach 1
FDA UDI
Class IUnknown
Eyewear By Roi Appleton Gold 1
FDA UDI
Class IUnknown
Eyewear By Roi Dean Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Sugan Wine 1
FDA UDI
Class IActive
Eyewear By Roi Jocelyn Black 1
FDA UDI
Class IActive
Eyewear By Roi Alectryon Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Segovia Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Pepino Red 1
FDA UDI
Class IActive

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