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ZOOM EYEWORKS DBA ICU EYEWEAR, INC.

US

Last updated May 23, 2026

What ZOOM EYEWORKS DBA ICU EYEWEAR, INC. makes

The company manufactures magnifying spectacles and tinted non-prescription spectacles, including tinted non-prescription spectacle lenses. These products are designed for visual enhancement and protection, catering to general eyewear needs without prescription adjustments.

All devices fall under FDA Class I regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Zoom Eyeworks (dba ICU Eyeware, Inc.) manufacture?

Zoom Eyeworks (dba ICU Eyeware, Inc.) specializes in magnifying spectacles and tinted non-prescription spectacles, including tinted non-prescription spectacle lenses. These devices are intended for general visual enhancement and eye protection without requiring a prescription. The focus is on non-corrective eyewear solutions for everyday use.

Where is Zoom Eyeworks (dba ICU Eyeware, Inc.) based?

Zoom Eyeworks (dba ICU Eyeware, Inc.) is based in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the U.S. regulatory framework for medical devices.

Which regulatory registries or databases list Zoom Eyeworks’ devices?

Zoom Eyeworks’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices under FDA oversight, ensuring traceability and compliance with U.S. regulations.

How are Zoom Eyeworks’ devices classified by the FDA?

All of Zoom Eyeworks’ devices fall under FDA Class I classification. This classification applies to low-risk devices that pose minimal potential harm to users, such as magnifying spectacles and tinted non-prescription lenses. Class I devices typically require general controls like proper labeling and manufacturing practices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
001952241

Catalogue (2588)

Page 11 of 52
DeviceModel / ReferenceRegistriesClassStatus
ICU Eyewear 77653401
FDA UDI
Class IActive
ICU Eyewear 78404207
FDA UDI
Class IActive
ICU Eyewear 78373407
FDA UDI
Class IActive
ICU Eyewear 12946
FDA UDI
Class IActive
ICU Eyewear 89623006
FDA UDI
Class IActive
ICU Eyewear 80421401
FDA UDI
Class IActive
ICU Eyewear 78383507
FDA UDI
Class IActive
ICU Eyewear 77190401
FDA UDI
Class IActive
ICU Eyewear 78404201
FDA UDI
Class IActive
ICU Eyewear 77171403
FDA UDI
Class IActive
ICU Eyewear 77191007
FDA UDI
Class IActive
ICU Eyewear 96100671
FDA UDI
Class IActive
ICU Eyewear 77760103
FDA UDI
Class IActive
ICU Eyewear 77983407
FDA UDI
Class IActive
ICU Eyewear 20620006Y
FDA UDI
Class IActive
ICU Eyewear 60263202
FDA UDI
Class IActive
ICU Eyewear 78036502
FDA UDI
Class IActive
ICU Eyewear 76503003
FDA UDI
Class IActive
ICU Eyewear 76103803ZX
FDA UDI
Class IActive
ICU Eyewear 7624300XMC
FDA UDI
Class IActive
ICU Eyewear 75896101TX
FDA UDI
Class IActive
ICU Eyewear 76143003
FDA UDI
Class IActive
ICU Eyewear 50484FE
FDA UDI
Class IActive
ICU Eyewear 11122665SFTX
FDA UDI
Class IActive
ICU Eyewear 75580305
FDA UDI
Class IActive
ICU Eyewear 78404401
FDA UDI
Class IActive
ICU Eyewear 78410207
FDA UDI
Class IActive
ICU Eyewear 75891501TX
FDA UDI
Class IActive
ICU Eyewear 20623008T
FDA UDI
Class IActive
ICU Eyewear 77073002
FDA UDI
Class IActive
ICU Eyewear 89570201
FDA UDI
Class IActive
ICU Eyewear 31700021
FDA UDI
Class IActive
ICU Eyewear 10120006SFX
FDA UDI
Class IActive
ICU Eyewear 20130405X
FDA UDI
Class IActive
ICU Eyewear 15648ZX
FDA UDI
Class IActive
ICU Eyewear 88490041
FDA UDI
Class IActive
ICU Eyewear 73441307
FDA UDI
Class IActive
ICU Eyewear 20127706X
FDA UDI
Class IActive
ICU Eyewear 7734140X
FDA UDI
Class IActive
ICU Eyewear 78181508
FDA UDI
Class IActive
ICU Eyewear 77983404
FDA UDI
Class IActive
ICU Eyewear WFWASVR225
FDA UDI
Class IActive
ICU Eyewear 76751408
FDA UDI
Class IActive
ICU Eyewear 41790304ZX
FDA UDI
Class IActive
ICU Eyewear 78120606
FDA UDI
Class IActive
ICU Eyewear 21245SFTX
FDA UDI
Class IActive
ICU Eyewear 77849903
FDA UDI
Class IActive
ICU Eyewear 74943303ZX
FDA UDI
Class IActive
ICU Eyewear 77753202
FDA UDI
Class IActive
ICU Eyewear 75910401TX
FDA UDI
Class IActive

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