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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 4 of 27
DeviceModel / ReferenceRegistriesClassStatus
Eyewear By Roi Mina Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Caracalla Blue 1
FDA UDI
Class IActive
Eyewear By Roi Brittany Mauve 1
FDA UDI
Class IActive
Eyewear By Roi Kirby Black 1
FDA UDI
Class IActive
Eyewear By Roi Tora Plum 1
FDA UDI
Class IUnknown
Eyewear By Roi Palenque Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Stopford Grey 1
FDA UDI
Class IActive
Eyewear By Roi Vika Cherry 1
FDA UDI
Class IUnknown
Eyewear By Roi Zimmer Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Amarillo Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Stitt Black Demi 1
FDA UDI
Class IActive
Eyewear By Roi Lorelei Pink/Grey 1
FDA UDI
Class IActive
Eyewear By Roi Constance Black 1
FDA UDI
Class IActive
Eyewear By Roi Ashburn Brown 1
FDA UDI
Class IActive
Eyewear By Roi Chayote Plum 1
FDA UDI
Class IUnknown
Eyewear By Roi Swansea Brown 1
FDA UDI
Class IActive
Eyewear By Roi Patchouli Rose 1
FDA UDI
Class IUnknown
Eyewear By Roi Atherton Brown 1
FDA UDI
Class IActive
Eyewear By Roi Greenwood Olive 1
FDA UDI
Class IUnknown
Eyewear By Roi Lolita Silver 1
FDA UDI
Class IUnknown
Eyewear By Roi Grandfalls Blue 1
FDA UDI
Class IActive
Eyewear By Roi Lady Fern Ruby 1
FDA UDI
Class IActive
Eyewear By Roi Atlantic City Gold 1
FDA UDI
Class IActive
Eyewear By Roi Burleson Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Arlette Chai 1
FDA UDI
Class IUnknown
Eyewear By Roi Brittany Mauve 1
FDA UDI
Class IUnknown
Eyewear By Roi Sammamish Gold/Green 1
FDA UDI
Class IActive
Eyewear By Roi Wood Rose Mocha 1
FDA UDI
Class IActive
Eyewear By Roi Decatur Black 1
FDA UDI
Class IActive
Eyewear By Roi Finzi Brown 1
FDA UDI
Class IActive
Eyewear By Roi Ixtapa Havana/Mint 1
FDA UDI
Class IUnknown
Eyewear By Roi Ernest Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Esme Crystal/Pink 1
FDA UDI
Class IActive
Eyewear By Roi Sydney Dark Gunmetal 1
FDA UDI
Class IUnknown
Eyewear By Roi Koa Tortoise 1
FDA UDI
Class IUnknown
Eyewear By Roi Levante Brown Stripe 1
FDA UDI
Class IUnknown
Eyewear By Roi Newport Black/Horn 1
FDA UDI
Class IActive
Eyewear By Roi Sumer Grey 1
FDA UDI
Class IActive
Eyewear By Roi Koa Tortoise 1
FDA UDI
Class IActive
Eyewear By Roi Jocelyn Brown 1
FDA UDI
Class IUnknown
Eyewear By Roi Sugan Black 1
FDA UDI
Class IUnknown
Eyewear By Roi Ashburn Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Hayes Shiny Grey 1
FDA UDI
Class IUnknown
Eyewear By Roi Garrison Black/Blue 1
FDA UDI
Class IUnknown
Eyewear By Roi Sharon Hill Wine 1
FDA UDI
Class IUnknown
Eyewear By Roi Rita Red 1
FDA UDI
Class IUnknown
Eyewear By Roi Blackcap Brown Multi 1
FDA UDI
Class IActive
Eyewear By Roi Segovia Black 1
FDA UDI
Class IActive
Eyewear By Roi Rubia Navy 1
FDA UDI
Class IActive
Eyewear By Roi Evans Navy/Silver 1
FDA UDI
Class IActive

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