Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEyewear 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
- —
- —
- [email protected]
- Phone
- +1(480)905-8020
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 177953189
Catalogue (1324)
Page 26 of 27Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.