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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
—
LinkedIn
—
Facebook
—
Phone
+1(480)905-8020
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
177953189

Catalogue (1324)

Page 9 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Port Hope Grey 1
FDA UDI
Class IActive
Eyewear By Roi Blount Grey 1
FDA UDI
Class IActive
Eyewear By Roi Karima Tortoise/Lime 1
FDA UDI
Class IActive
Eyewear By Roi Coronis Faded Rose 1
FDA UDI
Class IUnknown
Eyewear By Roi Sharon Hill Wine 1
FDA UDI
Class IActive
Eyewear By Roi Dulce Brown Fade 1
FDA UDI
Class IActive
Eyewear By Roi Burbank Gunmetal 1
FDA UDI
Class IActive
Eyewear By Roi Wiseman Black 1
FDA UDI
Class IActive
Eyewear By Roi York Navy 1
FDA UDI
Class IActive
Eyewear By Roi Alectryon Sunset 1
FDA UDI
Class IUnknown
Eyewear By Roi Lady Fern Ruby 1
FDA UDI
Class IUnknown
Eyewear By Roi Winterset Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Santo Domingo Matte Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Zipoli Brown/Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Newport Violet 1
FDA UDI
Class IUnknown
Eyewear By Roi Linstead Gold 1
FDA UDI
Class IUnknown
Eyewear By Roi Cannes Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Angusta Navy 1
FDA UDI
Class IUnknown
Eyewear By Roi Little Gem Forest 1
FDA UDI
Class IActive
Eyewear By Roi Katya Violet 1
FDA UDI
Class IUnknown
Eyewear By Roi Kokia Teal 1
FDA UDI
Class IUnknown
Eyewear By Roi Oscar Black 1
FDA UDI
Class IActive
Eyewear By Roi Cascade Eggplant 1
FDA UDI
Class IActive
Eyewear By Roi Fleecydale Purple 1
FDA UDI
Class IActive
Eyewear By Roi Fairy Moss Brown/Teal 1
FDA UDI
Class IActive
Eyewear By Roi Glinda Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Raina Brown/Red 1
FDA UDI
Class IUnknown
Eyewear By Roi Kudzu Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Asheville Black/Crystal 1
FDA UDI
Class IActive
Eyewear By Roi Jodie Bordeaux 1
FDA UDI
Class IUnknown
Eyewear By Roi Shalimar Graphite 1
FDA UDI
Class IUnknown
Eyewear By Roi Gayle Lilac 1
FDA UDI
Class IUnknown
Eyewear By Roi Beechworth Chocolate/Mint 1
FDA UDI
Class IActive
Eyewear By Roi Kudzu Purple 1
FDA UDI
Class IUnknown
Eyewear By Roi Shalimar Faded Rose 1
FDA UDI
Class IActive
Eyewear By Roi Annecy Rose 1
FDA UDI
Class IUnknown
Eyewear By Roi Viola Blue Crystal 1
FDA UDI
Class IActive
Eyewear By Roi Shantel Green 1
FDA UDI
Class IUnknown
Eyewear By Roi Kiltie Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Morgan Cayenne 1
FDA UDI
Class IActive
Eyewear By Roi Zuza Pink 1
FDA UDI
Class IActive
Eyewear By Roi Carver Brown 1
FDA UDI
Class IActive
Eyewear By Roi Charlene Violet 1
FDA UDI
Class IUnknown
Eyewear By Roi Santo Domingo Matte Grey 1
FDA UDI
Class IActive
Eyewear By Roi Cannes Brown 1
FDA UDI
Class IActive
Eyewear By Roi Byblos Blue 1
FDA UDI
Class IActive
Eyewear By Roi Franklinia Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Blount Brown 1
FDA UDI
Class IActive
Eyewear By Roi Lindley Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Allegra Blue 1
FDA UDI
Class IUnknown

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