Question 1

What types of medical devices does Eyewear By Roi, Limited manufacture?

Accepted Answer

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.

Question 2

Where is Eyewear By Roi, Limited based, and how does that affect its regulatory standing?

Accepted Answer

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.

Question 3

Which regulatory registries or databases list Eyewear By Roi, Limited’s spectacle frames?

Accepted Answer

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.

Question 4

How are Eyewear By Roi, Limited’s spectacle frames classified under FDA regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Eyewear By Roi Carulli Black	1	FDA UDI	Class I	Active
Eyewear By Roi Afton Brown	1	FDA UDI	Class I	Unknown
Eyewear By Roi Los Alamos Blue/Brown	1	FDA UDI	Class I	Unknown
Eyewear By Roi Saville Grey Fade	1	FDA UDI	Class I	Active
Eyewear By Roi Dexheimer Navy	1	FDA UDI	Class I	Active
Eyewear By Roi Gandalf Black	1	FDA UDI	Class I	Active
Eyewear By Roi Naomi Black	1	FDA UDI	Class I	Active
Eyewear By Roi Shantel Green	1	FDA UDI	Class I	Active
Eyewear By Roi Sorrel Black	1	FDA UDI	Class I	Unknown
Eyewear By Roi Atherton Brown	1	FDA UDI	Class I	Unknown
Eyewear By Roi Pella Lilac	1	FDA UDI	Class I	Unknown
Eyewear By Roi Piazzolla Black	1	FDA UDI	Class I	Active
Eyewear By Roi Fallbrook Navy	1	FDA UDI	Class I	Unknown
Eyewear By Roi Coronis Grey	1	FDA UDI	Class I	Active
Eyewear By Roi Cafferty Brown	1	FDA UDI	Class I	Unknown
Eyewear By Roi Barbary Fig Brown Demi	1	FDA UDI	Class I	Unknown
Eyewear By Roi Shangri La Brown	1	FDA UDI	Class I	Unknown
Eyewear By Roi Gwendolen Black	1	FDA UDI	Class I	Active
Eyewear By Roi Wilde Navy Multi	1	FDA UDI	Class I	Active
Eyewear By Roi Puccini Black/Brown	1	FDA UDI	Class I	Unknown
Eyewear By Roi Ambre Gold	1	FDA UDI	Class I	Active
Eyewear By Roi Cutner Black	1	FDA UDI	Class I	Unknown
Eyewear By Roi Flagami Violet	1	FDA UDI	Class I	Active
Eyewear By Roi Cinsault Brown	1	FDA UDI	Class I	Active

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