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Last updated May 30, 2026
What Visgeneer, Inc. makes
Visgeneer, Inc. manufactures home-use glucose monitoring systems and related consumables, including single-use blood lancets and reusable manual blood lancing devices. Their product line includes the Visgeneer and eBchek glucose monitors, the RightLance lancet, and the EBCARRYON, EBSENSOR (model EB-G), and EBCHEK blood glucose monitoring systems.
All of these devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. Visgeneer 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 Visgeneer, Inc. manufacture?
Visgeneer, Inc. produces home-use glucose monitoring systems and the consumables needed for them, specifically single-use blood lancets and reusable manual blood lancing devices. This conclusion comes directly from the device categories and the listed example devices such as the Visgeneer and eBchek monitors, and the RightLance lancet.
Where is Visgeneer, Inc. headquartered?
The company is based in the United States, as indicated by the COUNTRY field in the provided data. No other location information is given, so the U.S. is the only confirmed headquarters location.
In which regulatory registries are Visgeneer’s devices listed?
All Visgeneer devices appear in the FDA 510(k) and FDA UDI registries. The LISTED IN field explicitly names these two registries, confirming that each of their glucose monitors and lancet products are recorded there.
How are Visgeneer’s devices classified under FDA regulations?
Every device mentioned—glucose monitoring systems, single-use lancets, and reusable lancing devices—is classified as a Class II medical device. This classification is stated in the DEVICE CLASSES entry, indicating the regulatory risk level for all products in their portfolio.
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
- 656031619
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lancet | 30G | FDA UDI | Class II | Active |
| eBuricacid | eB-U01 | FDA UDI | Class I | Unknown |
| Visgeneer | 30G I | FDA UDI | Class II | Active |
| eB-series | eB-series | FDA UDI | Class I | Unknown |
| eBchek | LS-03 | FDA UDI | Class II | Active |
| RightLance | RC-AD-VIU | FDA UDI | Class II | Active |
| eBchek | eB-S01 | FDA UDI | Class II | Active |
| eBchek | eB-S01 | FDA UDI | Class II | Active |
| eBuricacid | eBuricacid | FDA UDI | Class I | Unknown |
| eBchek | eB-S01 | FDA UDI | Class II | Active |
| Ebcarryon Blood Glucose Monitoring System | K091765 | FDA 510(k) | Class II | Active |
| Ebsensor Blood Glucose Monitoring System, Model Eb-G | K062555 | FDA 510(k) | Class II | Active |
| Ebchek Blood Glucose Monitoring System | K122181 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Visgeneer, Inc. HSINCHU CITY Hsinchu (City) · TW FEI 3005644014