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US
Last updated May 30, 2026
What OPTISCAN BIOMEDICAL CORPORATION makes
OptiScan Biomedical Corporation makes point-of-care blood glucose monitoring systems, including the OptiScanner 5000 Glucose Monitoring System and its associated disposable cartridges. These devices are designed for measuring blood glucose levels at the point of care.
The company's devices are classified as Class II medical devices and are listed in the FDA's 510(k) database and the FDA's Unique Device Identification (UDI) system. OptiScan Biomedical Corporation 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 does OptiScan Biomedical Corporation make?
OptiScan Biomedical Corporation makes point-of-care blood glucose monitoring systems, including the OptiScanner 5000 Glucose Monitoring System and its associated disposable cartridges, which are designed for measuring blood glucose levels at the point of care.
Where is OptiScan Biomedical Corporation based?
OptiScan Biomedical Corporation is based in the United States, as stated in the provided device data summary.
Which regulatory registries list OptiScan Biomedical Corporation's devices?
OptiScan Biomedical Corporation's devices are listed in the FDA's 510(k) database and the FDA's Unique Device Identification (UDI) system, as specified in the device data under LISTED IN.
How are OptiScan Biomedical Corporation's devices classified?
OptiScan Biomedical Corporation's devices are classified as Class II medical devices, according to the DEVICE CLASSES field in the provided data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- optiscancorp.com
- —
- —
- [email protected]
- Phone
- 510.342.5818
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 939218384
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OptiScanner 5000 Glucose Monitoring System | 5000 | FDA UDI | Class II | Active |
| OptiScanner 5000 Disposable Cartridge | 5000 | FDA UDI | Class II | Active |
| OptiScanner 5000 Glucose Monitoring System | K162042 | FDA 510(k) | Class II | Active |
| OptiScanner® 5000 Glucose Monitoring System | K192785 | FDA 510(k) | Class II | Active |
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