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Sign in to claim this brandWhat CRYSTALVUE MEDICAL CORPORATION makes
CrystalVue Medical Corporation manufactures ophthalmic fundus cameras designed for retinal imaging, including models like the NFC-600, NFC-700, Polaris, Vitazi View™, RetinaStation, and Halo. These devices are intended for capturing high-resolution images of the retina to aid in the diagnosis and monitoring of eye conditions.
The company’s portfolio consists of Class II medical devices, all of which are listed in the FDA’s Unique Device Identifier (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 CrystalVue Medical Corporation manufacture?
CrystalVue Medical Corporation specializes in ophthalmic fundus cameras, which are devices used to capture detailed images of the retina. These cameras help healthcare professionals diagnose and monitor eye conditions by providing high-resolution visualizations of the back of the eye. Examples include the NFC-600, NFC-700, Polaris, Vitazi View™, RetinaStation, and Halo.
Where is CrystalVue Medical Corporation based?
CrystalVue Medical Corporation is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the U.S. healthcare system and adheres to domestic and international medical device standards.
Which regulatory registries list CrystalVue Medical Corporation’s devices?
CrystalVue Medical Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory oversight and market surveillance. This listing applies to all of their Class II devices.
How are CrystalVue Medical Corporation’s devices classified under medical device regulations?
CrystalVue Medical Corporation’s devices fall under Class II classification according to medical device regulations. Class II devices are generally considered to have an acceptable risk-to-benefit ratio when properly used, but they still require special controls to ensure safety and effectiveness. This classification applies to all their ophthalmic fundus cameras.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- crystalvue.com.tw
- —
- —
- [email protected]
- Phone
- +88633607711
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 658841648
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nfc-600 | NFC-600 | FDA UDI | Class II | Active |
| Nfc-700 | NFC-700 | FDA UDI | Class II | Active |
| Polaris | Polaris | FDA UDI | Class II | Active |
| Vitazi View™ | VitaziView | FDA UDI | Class II | Active |
| RetinaStation | RetinaStation | FDA UDI | Class II | Active |
| Halo | Halo | FDA UDI | Class II | Active |
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