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Sign in to claim this brandZOOM 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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- 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 1 of 52| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ICU Eyewear | 7669320XNP | FDA UDI | Class I | Active |
| ICU Eyewear | 10120002X | FDA UDI | Class I | Active |
| ICU Eyewear | 78043007 | FDA UDI | Class I | Active |
| ICU Eyewear | 88841401 | FDA UDI | Class I | Active |
| ICU Eyewear | 10500204CV | FDA UDI | Class I | Active |
| ICU Eyewear | 78361506 | FDA UDI | Class I | Active |
| ICU Eyewear | 78330502 | FDA UDI | Class I | Active |
| ICU Eyewear | 78180104 | FDA UDI | Class I | Active |
| ICU Eyewear | 78140508 | FDA UDI | Class I | Active |
| ICU Eyewear | 76500108 | FDA UDI | Class I | Active |
| ICU Eyewear | 12971 | FDA UDI | Class I | Active |
| ICU Eyewear | 10633006X | FDA UDI | Class I | Active |
| ICU Eyewear | 75470402 | FDA UDI | Class I | Active |
| ICU Eyewear | 31770102 | FDA UDI | Class I | Active |
| ICU Eyewear | 78233204 | FDA UDI | Class I | Active |
| ICU Eyewear | 10562304X | FDA UDI | Class I | Active |
| ICU Eyewear | 419612 | FDA UDI | Class I | Active |
| ICU Eyewear | 89341401 | FDA UDI | Class I | Active |
| ICU Eyewear | 15573ZX | FDA UDI | Class I | Active |
| ICU Eyewear | 31589910 | FDA UDI | Class I | Active |
| ICU Eyewear | 78036504 | FDA UDI | Class I | Active |
| ICU Eyewear | 15646ZX | FDA UDI | Class I | Active |
| ICU Eyewear | 60263204 | FDA UDI | Class I | Active |
| ICU Eyewear | 73446008 | FDA UDI | Class I | Active |
| ICU Eyewear | 76136104TX | FDA UDI | Class I | Active |
| ICU Eyewear | 77693206 | FDA UDI | Class I | Active |
| ICU Eyewear | 76123004 | FDA UDI | Class I | Active |
| ICU Eyewear | 12921 | FDA UDI | Class I | Active |
| ICU Eyewear | 20620004Y | FDA UDI | Class I | Active |
| ICU Eyewear | 20210002X | FDA UDI | Class I | Active |
| ICU Eyewear | 08146ZX | FDA UDI | Class I | Active |
| ICU Eyewear | 75580306 | FDA UDI | Class I | Active |
| ICU Eyewear | 78201706 | FDA UDI | Class I | Active |
| ICU Eyewear | 73819901TX | FDA UDI | Class I | Active |
| ICU Eyewear | 78043001 | FDA UDI | Class I | Active |
| ICU Eyewear | 77144508T | FDA UDI | Class I | Active |
| ICU Eyewear | 78220401 | FDA UDI | Class I | Active |
| ICU Eyewear | 78334403 | FDA UDI | Class I | Active |
| ICU Eyewear | 78281002 | FDA UDI | Class I | Active |
| ICU Eyewear | 78191505 | FDA UDI | Class I | Active |
| ICU Eyewear | 78291007 | FDA UDI | Class I | Active |
| ICU Eyewear | 77810604TX | FDA UDI | Class I | Active |
| ICU Eyewear | 78230402 | FDA UDI | Class I | Active |
| ICU Eyewear | 78320005 | FDA UDI | Class I | Active |
| ICU Eyewear | 73180405OD | FDA UDI | Class I | Active |
| ICU Eyewear | 50998410X | FDA UDI | Class I | Active |
| ICU Eyewear | 89360152 | FDA UDI | Class I | Active |
| ICU Eyewear | 12936 | FDA UDI | Class I | Active |
| ICU Eyewear | 71850302 | FDA UDI | Class I | Active |
| ICU Eyewear | 89642201 | FDA UDI | Class I | Active |
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